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 Ventlab Corp., Intertech Resources, Inc. and A Plus Medical.

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 Nov 23, 2009
VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
K092687
A Plus Medical
Anesthesiology · 83d
Cleared Feb 11, 2002
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
K020281
Ventlab Corp.
Anesthesiology · 14d
Cleared Dec 20, 2001
VENTLAB HYPERINFLATION BAG SYSTEM
K013308
Ventlab Corp.
Anesthesiology · 77d
Cleared Jun 13, 1997
SIMS HYPERINFLATION BAG SYSTEM
K970785
Sims
Anesthesiology · 101d
Cleared Jun 08, 1995
SIMS INTERTECH HYPERINFLATION BAG SYSTEM
K952214
Intertech Resources, Inc.
Anesthesiology · 28d
Cleared Jun 10, 1994
HYPER-INFLATION BAG
K942571
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Sep 08, 1989
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
K894612
Intertech Resources, Inc.
Anesthesiology · 50d
Cleared Mar 12, 1982
DISP. HYPERINFLATION BAG SYSTEM
K813317
Intec Medical, Inc.
Anesthesiology · 108d

About Product Code NHK - Regulatory Context