510(k) K001714

MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 by Mercury Medical — Product Code NHK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 3, 2000
Date Received: June 5, 2000
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.

Other clearances by Mercury Medical

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K090710 — MERCURY CPAP (August 20, 2009)
K083056 — NEO-STAT CO2 <KG (February 23, 2009)
K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
K031814 — STATCO2METER, MODEL 10-55372 (August 14, 2003)
K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (July 30, 2003)
K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (November 4, 2002)
K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (March 1, 2000)
K970756 — MERCURY MEDICAL REUSABLE CPR BAG (October 31, 1997)

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)
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)