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510(k) K911351

BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP by Biochem International, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1991
Date Received
March 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Biochem International, Inc.

  • K920083 — BIOCHEM MODEL 3302 NEWOX2 OXIMETER (April 11, 1994)
  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K921388 — BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE (May 26, 1993)
  • K920082 — BIOCHEM MODEL 3301 NEWOX1 OXIMETER (January 7, 1993)
  • K910381 — BIOCHEM TEMPERATURE/ FIO2 MODULE (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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