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510(k) K982112

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM by Thermatrek, Inc. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1998
Date Received
June 16, 1998
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

Other clearances by Thermatrek, Inc.

  • K030165 — THERMATREK IRIS-IV INFRARED IMAGING SYSTEM (April 16, 2003)

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