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FDA 510(k), K012512, SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k), K012512, SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
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510(K) Number: K012512
Device Name: SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Manufacturer: RADIANT MEDICAL
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 08/06/2001
Decision Date: 06/11/2002
Regulation Medical Specialty: Cardiovascular
Device Name: SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Manufacturer: RADIANT MEDICAL
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 08/06/2001
Decision Date: 06/11/2002
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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