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510(k) K031478

Device
MICROHEATER
Applicant
BELMONT INSTRUMENT CORP.
510(k) number
K031478
Product code
BSB  
Decision
Substantially Equivalent (SESE)
Decision date
2003-07-02
Date received
2003-05-12
Regulation
864.9205
Classification name
Warmer, Blood, Non-electromagnetic Radiation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
URAIWAN P LABADINI
Address
780 Boston Rd. Billerica MA US 01821 01821

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BSB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112639THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.2011-11-16
K090508THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.2009-03-26
K062774BELMONT BUDDY PLUS FLUID WARMERBelmont Instrument Corp.2006-10-19
K052547BELMONT BUDDY FLUID WARMERBelmont Instrument Corp.2005-10-13
K020060ASTOFLONats Corp.2002-03-05
K012031MODIFICATION TO THERMAL ANGELEstill Medical Technologies, Inc.2001-07-26
K991159PRISMATHERM II, ASTOLINEStihler Electronic GmbH1999-09-03
K991160ASTOTHERM PLUS, ASTOTUBES, ASTOLINEStihler Electronic GmbH1999-09-02
K984640THERMAL ANGELEstill Medical Technologies, Inc.1999-07-01
K973741BAIR HUGGER BLOOD/FLUID WARMERAugustine Medical, Inc.1998-04-30
K953741THERMACYL BLOOD/FLUID WARMERBaxter Healthcare Corp1996-06-26
K770232BLOOD/FLUID WARMER MODEL DW-1000AGorman Rupp Industries1977-02-14
K760012BLOOD WARMER (CODE 4R4305)Travenol Laboratories, S.A.1976-07-16

Legacy Summary#

summary

FDA Review#

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