Hepa Filtered Hme

• • Terminated Z-0961-05 FDA Unclassified (pre-2012) ·initiated 7 Jun 2005

  Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label

510(k) Number

K930816 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Resuscitation Bag Exhalation Filter

  Class II

  FDA 510(k) K883693 Active Cleared 30 Sep 1988

• 1ST Response Disposable Manometer

  Class II

  FDA 510(k) K961318 Active Cleared 17 Dec 1996

• 1ST Response (Tm) Infant Manual Resuscitator

  Class II

  FDA 510(k) K902733 Active Cleared 22 Aug 1990

• Intertech Newborn Hyperinflation Bag System

  Class II

  FDA 510(k) K894612 Active Cleared 8 Sep 1989

• Intertech/Inspiron (R) Medication Nebulizer Kit

  Class II

  FDA 510(k) K896923 Active Cleared 12 Mar 1990

• Disposable Anesthesia Breathing Circuits, Modified

  Class I

  FDA 510(k) K912065 Active Cleared 23 Oct 1991

See all devices from Intertech Resources, Inc. →