510(k) K171928

Med-Hot Thermal Imaging Systems by Med-Hot Thermal Imaging, Inc. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2017
Date Received
June 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type