FDA 510(k) Application Details - K953741

Device Classification Name	Warmer, Blood, Non-Electromagnetic Radiation   More FDA Info for this Device
510(K) Number	K953741
Device Name	Warmer, Blood, Non-Electromagnetic Radiation
Applicant	BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. ROUND LAKE, IL 60073 US Other 510(k) Applications for this Company
Contact	JODY ANN GOULD Other 510(k) Applications for this Contact
Regulation Number	864.9205   More FDA Info for this Regulation Number
Classification Product Code	BSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/1995
Decision Date	06/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review