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510(k) K930816

HEPA FILTERED HME by Intertech Resources, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1993
Date Received
February 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

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)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 30, 1992)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)

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