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FDA 510(k), K080899, ARCTIC BLAST INTRAVENOUS FLUID CHILLER
FDA 510(k), K080899, ARCTIC BLAST INTRAVENOUS FLUID CHILLER
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$149.00 USD
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510(K) Number: K080899
Device Name: ARCTIC BLAST INTRAVENOUS FLUID CHILLER
Manufacturer: MEDIVANCE, INC.
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 03/31/2008
Decision Date: 08/07/2008
Regulation Medical Specialty: Cardiovascular
Device Name: ARCTIC BLAST INTRAVENOUS FLUID CHILLER
Manufacturer: MEDIVANCE, INC.
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 03/31/2008
Decision Date: 08/07/2008
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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