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510(k) K063047

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM by Medhot Thermal Imaging, Inc. — Product Code LHQ

K063047 is an FDA 510(k) premarket notification submitted by Medhot Thermal Imaging, Inc. for the device "MEDHOT MTI 2000 THERMAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2006. 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
October 19, 2006
Date Received
October 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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