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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 K861534
Device Name MODEL 450 INFRARED IMAGING SYSTEM
Applicant
Mitek , Inc.
2572 Us Hwy. 41 W.
Marquette,  MI  49855
Applicant Contact CAROL A MOORE
Correspondent
Mitek , Inc.
2572 Us Hwy. 41 W.
Marquette,  MI  49855
Correspondent Contact CAROL A MOORE
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received04/24/1986
Decision Date 07/18/1986
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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