Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Resuscitator, Manual, Non Self-Inflating

FDA product code NHK · 10 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5905
Review panel
AN
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
1982-03-12 – 2009-11-23

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

↑