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510(k) K853018

MODEL 3000 OPTICATH COMPUTER by Oximetrix, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
July 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Oximetrix, Inc.

  • 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)
  • K811391 — OXIMETRIX ACCU SAT CPB (July 20, 1981)
  • 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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  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)