510(k) K030165

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM by Thermatrek — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2003
Date Received
January 16, 2003
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