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510(k) K781879

HEATER, OXIMETER SYSTEM by Oximetrix, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1979
Date Received
November 6, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • K811391 — OXIMETRIX ACCU SAT CPB (July 20, 1981)
  • K791868 — OXIMETRIX SHAW HEMOSTATIC SURG. SYS. (January 4, 1980)
  • K781134 — CATHETER, THERMAL DILUTION FIBEROPTIC (August 17, 1978)

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