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510(k) K181716

InTouch Thermal Camera by Intouch Technologies, Inc., D.B.A. Intouch Health — Product Code LHQ

K181716 is an FDA 510(k) premarket notification submitted by Intouch Technologies, Inc., D.B.A. Intouch Health for the device "InTouch Thermal Camera". The FDA issued a decision of Substantially Equivalent on March 25, 2019. 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
March 25, 2019
Date Received
June 28, 2018
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