FDA 510(k) Application Details - K181716

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K181716
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	InTouch Technologies, Inc., d.b.a. InTouch Health 7402 Hollister Avenue Goleta, CA 93117 US Other 510(k) Applications for this Company
Contact	Karen Mullin 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	06/28/2018
Decision Date	03/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review