FDA 510(k) Application Details - K112116

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K112116
Device Name	Thermometer, Electronic, Clinical
Applicant	AMPEROR-ELECTRONIC(SZ) CO., LTD 250 TURNPIKE ROAD SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	RAJ KASBEKAR 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	07/25/2011
Decision Date	10/04/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review