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510(k) K200999

Thermidas IR System (ThIR-A615) by Thermidas Americas, Inc. — Product Code LHQ

K200999 is an FDA 510(k) premarket notification submitted by Thermidas Americas, Inc. for the device "Thermidas IR System (ThIR-A615)". The FDA issued a decision of Substantially Equivalent on January 6, 2021. 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
January 6, 2021
Date Received
April 16, 2020
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