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510(k) K921388

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE by Biochem International, Inc. — Product Code DSK

K921388 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Biochem International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
March 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
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)
  • K920082 — BIOCHEM MODEL 3301 NEWOX1 OXIMETER (January 7, 1993)
  • K911351 — BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (August 22, 1991)
  • 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)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources