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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K843549
Device Name PROBEYE THERMAL VIDEO SYSTEMS
Applicant
Hughes Aircraft Co.
6155 Camino Real
Carlsbad,  CA  92008
Applicant Contact IRWIN B GALTER
Correspondent
Hughes Aircraft Co.
6155 Camino Real
Carlsbad,  CA  92008
Correspondent Contact IRWIN B GALTER
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received09/10/1984
Decision Date 02/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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