FDA 510(k) Application Details - K983355

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K983355
Device Name	Thermometer, Electronic, Clinical
Applicant	SABRATEK CORP. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071-3404 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	880.2910   More FDA Info for this Regulation Number
Classification Product Code	FLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/1998
Decision Date	03/12/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review