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510(k) K870911

INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY by American Bentley — Product Code CCC

K870911 is an FDA 510(k) premarket notification submitted by American Bentley for the device "INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY". The FDA issued a decision of Substantially Equivalent on May 29, 1987. 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. American Bentley has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1987
Date Received
March 6, 1987
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 American Bentley

  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)
  • K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (November 6, 1987)
  • K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (September 1, 1987)
  • K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (September 1, 1987)
  • K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS (August 24, 1987)
  • K870269 — ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (March 9, 1987)
  • K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS (October 20, 1986)
  • K861641 — HEPARIN-COATED EXTRACORPOREAL CIRCUITS (September 29, 1986)
  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)
  • K860673 — OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (June 26, 1986)

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