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510(k) K181716

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

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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