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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 K844771
Device Name INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
Applicant
Image Systems, Inc.
430 10th.St.Nwsuite N-209
Atlanta,  GA  30318
Applicant Contact RICHARD P HARTWIG
Correspondent
Image Systems, Inc.
430 10th.St.Nwsuite N-209
Atlanta,  GA  30318
Correspondent Contact RICHARD P HARTWIG
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received12/07/1984
Decision Date 02/27/1985
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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