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510(k) K023434

DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM by Dorex, Inc. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2002
Date Received
October 15, 2002
Clearance Type
Special
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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