FDA 510(k) Application Details - K001281

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K001281
Device Name	Thermometer, Electronic, Clinical
Applicant	GERATHERM AG 2000 TOWN CENTER SUITE 1900 SOUTHFIELD, MI 48075-2645 US Other 510(k) Applications for this Company
Contact	ED HOLTER 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	04/21/2000
Decision Date	06/12/2001
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