Created by respiratory therapists to help you save lives.

International Regulatory Compliance Information

Under regulatory compliance, our goal is to take steps to comply with relevant laws, policies, and regulations for medical device manufacturing and marketing Airon products. All Airon products are designed, manufactured, and supported based upon sound quality procedures. Every device is CE marked as well as USA FDA cleared.

Product Certification and Approvals

USA – FDA Free Sale Certificate – Certificate to Foreign Government

Canada – Medical Device Licenses
pNeuton ventilator license | MACS license | patient circuit license

Europe – CE Marking certificates – Airon EC Certificate

Europe – Declarations of Conformity

USA – FDA 510(k) cleared
pNeuton A | pNeuton S | MACS | pNeuton mini

Global Regulatory Representative

Europe – Authorized Representative

Emergo Europe
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
Telephone: +31.70.345.8570

Critical Care ventilation with CPAP for ER, MRI, OR, ICU, and transport

Our critical care ventilation + CPAP products are fully pneumatic, lightweight, portable, and easy-to-use.

Suitable for ER / trauma to special procedures and MRI, to the OR, ICU and intra or inter-facility transports via air or ground–you’ll have what you need for any patient, anywhere.

Intended for continuous ventilation of adult / pediatric patients 23 kg and greater who require the following general types of ventilatory support: 

• Positive pressure ventilation delivered invasively, non-invasively or with CPAP
• CMV and IMV ventilation modes
• With / without PEEP/CPAP
• With oxygen or a mix of air and oxygen

Both the pNeuton Model A and S are MRI compatible with no Gauss line restriction–the device can be placed next to the magnet.

The pNeuton Model A enhances patient safety with its integrated, all-pneumatic remote alarm for patient circuit disconnects and low gas supply from the bedside to the MRI observation room.

Neonatal and pediatric life support ventilation for even the most fragile patients

Our critical care neonatal // infant / pediatric ventilators + CPAP products are fully pneumatic, small, lightweight, portable, and easy-to-use.

Suitable for ER, Delivery, MRI / Radiology, OR, Recovery, NICU and intra or inter-facility transports via air or ground–you’ll have what you need for any patient, anywhere.

Intended for continuous ventilation of neonatal / infant / child patients 400 grams to 20 kg.

who require the following general types of ventilatory support: 

• Positive pressure ventilation delivered invasively, non-invasively or with CPAP
• CMV and IMV ventilation modes
• With / without PEEP/CPAP
• With oxygen or a mix of air and oxygen

Both the pNeuton mini and the pNeuton NEO are:

• Able to match the complexity of pressure-limited ventilation in standard infant ventilators
• Easy-to-use with full range FiO2
• Compatible with the Life Pulse High-Frequency Jet Ventilator from Bunnell Incorporated, providing conventional ventilation in tandem with the Life Pulse without interfering with high frequency ventilation or nuisance alarms
• MRI compatible and have an integrated remote alarm to enhance patient safety
• Built for in-hospital transport, as well as via ground, helicopter or fixed wing

pNeuton ventilators overcome MRI concerns

Conventional medical devices and accessories were not designed for the harsh magnetic resonance (MR) environment that uses electromagnetic fields.

Airon’s line of pNeuton ventilators are built with our innovative pneumatic technology, and non-ferrous materials, so their performance does not interfere or cause artifact with the testing results.

Our pNeuton ventilators:

• Are fully pneumatic – No batteries or electricity needed
• Will not experience any electronic degradation over time that can malfunction as a result of interference from MR systems and cause service or repair costs
• Can be placed right next to the magnet without needing to be permanently fixed to the floor or tethered to prevent missile-related accidents
• Eliminate the need for Gauss line requirements
• Are built without magnetic materials and have been test certified to minimize image artifact
• Enhance patient safety with an integrated all-pneumatic alarm system with remote alarm for patient circuit disconnects and low gas supply from the bedside to the MRI observation room

Advanced critical care CPAP for EMS with and without ventilation

When you need critical care support in the field, Airon’s MACS stand-alone CPAP System, and pNeuton Model S transport ventilator with built-in CPAP are the devices EMS professionals prefer.

MACS is a small, lightweight, pneumatic Continuous Positive Airway Pressure (CPAP) system designed for use on spontaneously breathing patients requiring up to 140 L/min oxygen at 65% or 100% concentrations.

The CPAP system provides expiratory positive pressure delivered non-invasively or invasively.

Suitable for use in pre-hospital and hospital settings, ER, OR, Recovery, accident scenes, and intra and inter-hospital transport.

The pNeuton Model S is intended for continuous ventilation of adult / pediatric patients 23 kg and greater who require the following general types of ventilatory support: 

• Positive pressure ventilation delivered invasively, non-invasively or with CPAP
• CMV and IMV ventilation modes
• With / without PEEP/CPAP
• With oxygen or a mix of air and oxygen

Suitable for use in pre-hospital transport applications including accident scenes, emergency rescue vehicles, hospital ICU transport applications including emergency, radiology, OR, post-anesthesia / recovery and MRI departments. Ground or air transport via helicopter or fixed wing.

The pNeuton Model S is MRI compatible with no Gauss line restriction–the device can be placed next to the magnet.

Both the MACS and the pNeuton Model S are built for ground or air transport, and have met the US Army Air Worthiness Certification requirements.