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510(k) K212965

Smile-100 System by Niramai Health Analytix Private Limited — Product Code LHQ

K212965 is an FDA 510(k) premarket notification submitted by Niramai Health Analytix Private Limited for the device "Smile-100 System". The FDA issued a decision of Substantially Equivalent on March 10, 2022. 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 10, 2022
Date Received
September 16, 2021
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