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510(k) K961838

RESPIRGARD II, SPIROGARD by Marquest Medical Products, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
May 13, 1996
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 Marquest Medical Products, Inc.

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  • K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS (October 18, 1996)
  • K904690 — TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM (February 1, 1991)
  • K903138 — MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM (October 11, 1990)
  • K902632 — GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS (September 4, 1990)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)
  • K880979 — MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM (July 15, 1988)

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