FDA 510(k), K031544, HEATER COOLER UNIT, MODEL HCU 30

FDA 510(k), K031544, HEATER COOLER UNIT, MODEL HCU 30

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510(K) Number: K031544
Device Name: HEATER COOLER UNIT, MODEL HCU 30
Manufacturer:
Device Classification Name: Controller, Temperature, Cardiopulmonary Bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 05/16/2003
Decision Date: 08/07/2003
Regulation Medical Specialty: Cardiovascular
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