510(k) K942571

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

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)
K942569 — VENTILATOR HOSE (June 10, 1994)
K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
K942570 — MAPLESON D CIRCUIT (June 10, 1994)
K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)
K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
K932577 — PEDIATRIC GAS SAMPLING (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)