FDA 510(k) Application Details - K162767

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K162767
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	First Sense Medical, LLC 2001 Centerpoint Parkways, Suite 110 Pontiac, MI 48341 US Other 510(k) Applications for this Company
Contact	Alan Alan Klevens Other 510(k) Applications for this Contact
Regulation Number	884.2980   More FDA Info for this Regulation Number
Classification Product Code	LHQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2016
Decision Date	01/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review