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510(k) K001714

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

K001714 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149". The FDA issued a decision of Substantially Equivalent on November 3, 2000. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. Mercury Medical has at least 10 other 510(k) clearances on record.

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

  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (April 6, 2010)
  • 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)

FDA data resources