O-Two Systems Intl., Inc.
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- Devices
- 14
What O-Two Systems Intl., Inc. makes
O-Two Systems Intl., Inc. manufactures manual and automated ventilation devices, including bag-mask units (adult, pediatric, and emergency), emergency resuscitators, and mouth-to-mask ventilation aids. Their portfolio also includes portable ventilators for basic life support (BLS) and advanced life support (ALS), as well as specialized respiratory support units for hazardous environments and CPR bio-barrier faceshields. Automated models feature programmable ventilation modes for pre-hospital and emergency care settings.
The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance for use in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does O-Two Systems Intl., Inc. have in the registry?
The registry currently lists 14 devices for O-Two Systems Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list O-Two Systems Intl., Inc.'s devices?
Among its 14 most recently registered devices, O-Two Systems Intl., Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do O-Two Systems Intl., Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for O-Two Systems Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from O-Two Systems Intl., Inc. in the registry?
The most recently registered devices listed for O-Two Systems Intl., Inc. include FLYNN SERIES III BAG/MASK UNIT-, AUTOVENT 1000, EMT RESUSCITATOR and PPM III.