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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 K101641
Device Name AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
Applicant
Ag Digital Technology Corp.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Ag Digital Technology Corp.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received06/10/2010
Decision Date 06/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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