510(k) K813317

DISP. HYPERINFLATION BAG SYSTEM by Intec Medical, Inc. — Product Code NHK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 12, 1982
Date Received: November 24, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Resuscitator, Manual, Non Self-Inflating
Device Class: Class II
Regulation Number: 868.5905
Review Panel: AN
Submission Type

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.

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K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY (October 16, 1990)
K903906 — PERCUTANEOUS CATHETER INTRODUCER KIT (September 26, 1990)
K900998 — INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE (August 14, 1990)
K901247 — TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (July 31, 1990)
K894925 — AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (December 13, 1989)
K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)

Other clearances for product code NHK

K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (November 23, 2009)
K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM (February 11, 2002)
K013308 — VENTLAB HYPERINFLATION BAG SYSTEM (December 20, 2001)
K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
K970785 — SIMS HYPERINFLATION BAG SYSTEM (June 13, 1997)
K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
K942571 — HYPER-INFLATION BAG (June 10, 1994)
K940255 — HYPERINFLATION BAG SYSTEM (February 17, 1994)
K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (September 8, 1989)