FDA 510(k) Application Details - K161933

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K161933
Device Name	Thermometer, Electronic, Clinical
Applicant	Kaz USA, Inc., A Helen of Troy Company 400 DONALD LYNCH BLVD., SUITE 300 MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	AMY LIU 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	07/14/2016
Decision Date	08/16/2016
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