FDA 510(k) Application Details - K170662

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K170662
Device Name	Thermometer, Electronic, Clinical
Applicant	Intrinity Global Limited Room 1707, 17/F, Westley Square 48Hoi Yuen Road, Kwun Tong Hong Kong 999077 CN Other 510(k) Applications for this Company
Contact	Alex Kwok 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	03/03/2017
Decision Date	11/22/2017
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