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Oximetrix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K853018MODEL 3000 OPTICATH COMPUTERJanuary 13, 1986
K842622HEMO STATIC/ESU SCALPEL SYSTEMOctober 23, 1984
K833966PUMP INFUSION WEARABLE INFUSION PUMPJanuary 25, 1984
K823007OPTICATH HEPARIN COATED, FLOW-DIRECTNovember 1, 1982
K821057FLOW DIRECTED THERMAL-DILUTION INFUSIONMay 18, 1982
K821056FLOW DIRECTED THERMAL-DILUTION CATHETERMay 18, 1982
K820674OPTICATHMarch 25, 1982
K811391OXIMETRIX ACCU SAT CPBJuly 20, 1981
K791868OXIMETRIX SHAW HEMOSTATIC SURG. SYS.January 4, 1980
K781879HEATER, OXIMETER SYSTEMJanuary 8, 1979
K781134CATHETER, THERMAL DILUTION FIBEROPTICAugust 17, 1978
K760234OXIMETER, IN VIVO CATHETERAugust 23, 1976