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510(k) K212412

IRIS-XP by Medicore Co., Ltd. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2021
Date Received
August 3, 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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