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510(k) K894612

INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM by Intertech Resources, Inc. — Product Code NHK

K894612 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
July 20, 1989
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 Intertech Resources, Inc.

  • K961318 — 1ST RESPONSE DISPOSABLE MANOMETER (December 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K930816 — HEPA FILTERED HME (July 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 30, 1992)

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)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K940255 — HYPERINFLATION BAG SYSTEM (February 17, 1994)
  • K813317 — DISP. HYPERINFLATION BAG SYSTEM (March 12, 1982)

FDA data resources