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510(k) K901861

BIOCHEM 9100 MULTIGAS MONITOR by Biochem International, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
April 25, 1990
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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  • K920082 — BIOCHEM MODEL 3301 NEWOX1 OXIMETER (January 7, 1993)
  • K910381 — BIOCHEM TEMPERATURE/ FIO2 MODULE (August 22, 1991)
  • K911351 — BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (August 22, 1991)
  • K903222 — BIOCHEM 6100 NON-INVASIVE MONITOR (September 4, 1990)
  • K893877 — BIOCHEM 3100 OXIMETER (December 20, 1989)
  • K892646 — BIOCHEM 8100 ANESTHETIC AGENT MONITOR (August 31, 1989)
  • K890874 — BIOCHEM 520 BREATH INDICATOR (June 15, 1989)

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