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FDA 510(k), K101589, BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
FDA 510(k), K101589, BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
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510(K) Number: K101589
Device Name: BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Manufacturer: CINCINNATI SUB-ZERO PRODUCTS, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/07/2010
Decision Date: 09/20/2010
Regulation Medical Specialty: Cardiovascular
Device Name: BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Manufacturer: CINCINNATI SUB-ZERO PRODUCTS, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/07/2010
Decision Date: 09/20/2010
Regulation Medical Specialty: Cardiovascular
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