FDA 510(k) Applications for Medical Device Product Code "BSB"
(Warmer, Blood, Non-Electromagnetic Radiation)

FDA 510(k) Number Applicant Device Name Decision Date
K973741 AUGUSTINE MEDICAL, INC. BAIR HUGGER BLOOD/FLUID WARMER 04/30/1998
K953741 BAXTER HEALTHCARE CORP. THERMACYL BLOOD/FLUID WARMER 06/26/1996
K052547 BELMONT INSTRUMENT CORP. BELMONT BUDDY FLUID WARMER 10/13/2005
K062774 BELMONT INSTRUMENT CORP. BELMONT BUDDY PLUS FLUID WARMER 10/19/2006
K031478 BELMONT INSTRUMENT CORP. MICROHEATER 07/02/2003
K090508 BELMONT INSTRUMENT CORP. THE BELMONT BUDDY LITE FLUID WARMER 03/26/2009
K112639 BELMONT INSTRUMENT CORP. THE BELMONT BUDDY LITE FLUID WARMER 11/16/2011
K012906 ELLTEC CO., LTD. ANIMEC, MODELS AM-2S-4 AND AM-2S-5 10/09/2001
K024373 ELLTEC CO., LTD. MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 01/28/2003
K012031 ESTILL MEDICAL TECHNOLOGIES, INC. MODIFICATION TO THERMAL ANGEL 07/26/2001
K984640 ESTILL MEDICAL TECHNOLOGIES, INC. THERMAL ANGEL 07/01/1999
K770232 GORMAN RUPP INDUSTRIES BLOOD/FLUID WARMER MODEL DW-1000A 02/14/1977
K020060 NATS CORP. ASTOFLO 03/05/2002
K991160 STIHLER ELECTRONIC GMBH ASTOTHERM PLUS, ASTOTUBES, ASTOLINE 09/02/1999
K991159 STIHLER ELECTRONIC GMBH PRISMATHERM II, ASTOLINE 09/03/1999
K760012 TRAVENOL LABORATORIES, S.A. BLOOD WARMER (CODE 4R4305) 07/16/1976


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