FDA 510(k) Application Details - K050137

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K050137
Device Name	Thermometer, Electronic, Clinical
Applicant	XILAS MEDICAL, INC. 12665 SILICON DR. SAN ANTONIO, TX 78249-3412 US Other 510(k) Applications for this Company
Contact	RUBEN G ZAMORANO 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	01/24/2005
Decision Date	03/18/2005
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