510(k) K013308

VENTLAB HYPERINFLATION BAG SYSTEM by Ventlab Corp. — Product Code NHK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 20, 2001
Date Received: October 4, 2001
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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K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT (December 10, 2009)
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K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD (August 13, 2008)
K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (March 26, 2008)
K040726 — VENTLAB NASAL CPAP CANNULA (June 3, 2004)
K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100 (July 7, 2003)

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)
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)
K813317 — DISP. HYPERINFLATION BAG SYSTEM (March 12, 1982)