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510(k) K171928

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

K171928 is an FDA 510(k) premarket notification submitted by Med-Hot Thermal Imaging, Inc. for the device "Med-Hot Thermal Imaging Systems". The FDA issued a decision of Substantially Equivalent on December 8, 2017. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980.

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

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FDA data resources