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510(k) K811391

OXIMETRIX ACCU SAT CPB by Oximetrix, Inc. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
May 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

Other clearances by Oximetrix, Inc.

  • K853018 — MODEL 3000 OPTICATH COMPUTER (January 13, 1986)
  • K842622 — HEMO STATIC/ESU SCALPEL SYSTEM (October 23, 1984)
  • K833966 — PUMP INFUSION WEARABLE INFUSION PUMP (January 25, 1984)
  • K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT (November 1, 1982)
  • K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION (May 18, 1982)
  • K821056 — FLOW DIRECTED THERMAL-DILUTION CATHETER (May 18, 1982)
  • K820674 — OPTICATH (March 25, 1982)
  • K791868 — OXIMETRIX SHAW HEMOSTATIC SURG. SYS. (January 4, 1980)
  • K781879 — HEATER, OXIMETER SYSTEM (January 8, 1979)
  • K781134 — CATHETER, THERMAL DILUTION FIBEROPTIC (August 17, 1978)

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  • K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (March 28, 2018)
  • K163657 — Quantum Workstation (January 18, 2017)
  • K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF (October 23, 2014)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)