FDA 510(k), K053645, MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
FDA 510(k), K053645, MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
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510(K) Number: K053645
Device Name: MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
Manufacturer: ARIZANT HEALTHCARE INC.
Device Classification Name: system, thermal regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 12/30/2005
Decision Date: 03/09/2006
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
Manufacturer: ARIZANT HEALTHCARE INC.
Device Classification Name: system, thermal regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 12/30/2005
Decision Date: 03/09/2006
Regulation Medical Specialty: Cardiovascular