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510(k) K942571

HYPER-INFLATION BAG by Med-Plastics Intl., Inc. — Product Code NHK

K942571 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "HYPER-INFLATION BAG". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
May 31, 1994
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 Med-Plastics Intl., Inc.

  • K946209 — DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (June 8, 1995)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942570 — MAPLESON D CIRCUIT (June 10, 1994)
  • K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
  • K932577 — PEDIATRIC GAS SAMPLING (July 22, 1993)
  • K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
  • K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)
  • K932578 — ADULT GAS SAMPLING CIRCUITS (July 22, 1993)

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)
  • 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