FDA 510(k) Application Details - K162137

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K162137
Device Name	Thermometer, Electronic, Clinical
Applicant	VivaLnk Inc. 4655 Old Ironsides Dr. #390 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Cecilia Xi 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	08/01/2016
Decision Date	01/19/2017
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