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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK150301
Tradename The Belmont buddy(TM) 2 Blood/Fluid Warmer
Device Name Device, Warming, Blood and Plasma
Original Applicant
Belmont Instrument Corporation
780 boston road
billerica,  MA  01821
Regulation Number864.9205
Classification Product Code
KZL  
Date Received08/11/2015
Decision Date 09/02/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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