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510(k) K960972

DISPOSABLE GAS SAMPLING INTERFACE KITS by Marquest Medical Products, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
March 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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  • K961838 — RESPIRGARD II, SPIROGARD (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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