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510(k) K910381

BIOCHEM TEMPERATURE/ FIO2 MODULE by Biochem International, Inc. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

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  • K911351 — BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (August 22, 1991)
  • K903222 — BIOCHEM 6100 NON-INVASIVE MONITOR (September 4, 1990)
  • K901861 — BIOCHEM 9100 MULTIGAS MONITOR (July 27, 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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