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510(k) K771722

SENSOMAT by Biochem International, Inc. — Product Code CCC

K771722 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "SENSOMAT". The FDA issued a decision of Substantially Equivalent on September 26, 1977. The device falls under product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1150. Biochem International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1977
Date Received
September 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1150
Review Panel
AN
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)
  • 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)

Other clearances for product code CCC

  • K071165 — ISCALERT SENSOR SYSTEM (November 7, 2007)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 1999)
  • K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIO (December 19, 1997)
  • K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 4, 1997)
  • K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (April 9, 1997)
  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K940188 — PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 13, 1995)
  • K931185 — SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (October 21, 1993)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)

FDA data resources