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510(k) K874395

RESPIRGARD II NEBULIZER SYSTEM by Marquest Medical Products, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1987
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS (October 18, 1996)
  • 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)

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