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510(k) K920083

BIOCHEM MODEL 3302 NEWOX2 OXIMETER by Biochem International, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1994
Date Received
January 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Biochem International, Inc.

  • 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)
  • 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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