FDA 510(k) Application Details - K023510

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K023510
Device Name	Thermometer, Electronic, Clinical
Applicant	TRUTEK, INC. P.O. BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith 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	10/21/2002
Decision Date	02/04/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review