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510(k) K970478

SCT 3000 HEATED HUMIDIFIER by Marquest Medical Products, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1997
Date Received
February 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Marquest Medical Products, Inc.

  • K050066 — C-CO2 COLORIMETRIC CO2 INDICATOR (March 1, 2005)
  • K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K961838 — RESPIRGARD II, SPIROGARD (October 18, 1996)
  • 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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