NHK · Class II · 21 CFR 868.5905

FDA Product Code NHK: Resuscitator, Manual, Non Self-inflating

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.

Leading manufacturers include Intertech Resources, Inc..

10
Total
10
Cleared
65d
Avg days
1982
Since

FDA 510(k) Cleared Resuscitator, Manual, Non Self-inflating Devices (Product Code NHK)

10 devices
1–10 of 10
Cleared Jun 08, 1995
SIMS INTERTECH HYPERINFLATION BAG SYSTEM
K952214
Intertech Resources, Inc.
Anesthesiology · 28d
Cleared Sep 08, 1989
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
K894612
Intertech Resources, Inc.
Anesthesiology · 50d

About Product Code NHK - Regulatory Context