NHK

Resuscitator, Manual, Non Self-Inflating

Product code

NHK

Device name

Resuscitator, Manual, Non Self-Inflating

Device class

Class 2

21 CFR

21 CFR 868.5905

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).