NHK

10 FDA 510(k) clearances · Product code

FDA profile

Official device name

Resuscitator, Manual, Non Self-Inflating

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5905

Medical specialty

Anesthesiology

Flags

Life-sustaining

FDA 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.

Adverse events (MAUDE)

2014: 15 · 2015: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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