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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, Infrared
510(k) Number K863736
Device Name FMS MODEL 110
Applicant
Flir Medical Systems
16505 SW 72nd Ave.
Portland,  OR  97224
Applicant Contact CLARK W WINGERT
Correspondent
Flir Medical Systems
16505 SW 72nd Ave.
Portland,  OR  97224
Correspondent Contact CLARK W WINGERT
Regulation Number884.2980
Classification Product Code
IYM  
Date Received09/23/1986
Decision Date 12/29/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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