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510(k) K781271

MONITOR, PO2, INTRAVASCULAR by Roche Medical Electronics, Inc. — Product Code CCE

K781271 is an FDA 510(k) premarket notification submitted by Roche Medical Electronics, Inc. for the device "MONITOR, PO2, INTRAVASCULAR". The FDA issued a decision of Substantially Equivalent on October 12, 1978. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Roche Medical Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1978
Date Received
July 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type

Other clearances by Roche Medical Electronics, Inc.

  • K791559 — ROCHE SENSOR ADAPTOR (November 21, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K790421 — ROCHE LACTATE ANALYZER 640 (May 15, 1979)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)

Other clearances for product code CCE

  • K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (December 5, 1996)
  • K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (May 5, 1992)
  • K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE (August 13, 1991)
  • K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (May 14, 1991)
  • K896311 — OPTEX BLOOD GAS MONITORING SYSTEM (January 3, 1990)
  • K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II (December 22, 1989)
  • K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (November 28, 1989)
  • K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (November 28, 1989)
  • K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (December 16, 1988)
  • K875225 — UMBILICAL ARTERY OXYGEN SENSOR (March 4, 1988)

FDA data resources