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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K843437
Device Name MEI MAMMOGRAPHY SYS MX-2049
Applicant
Moti Enterprises, Inc.
11177 E. Seven Mile Rd.
Detroit,  MI  48234
Applicant Contact MOTI
Correspondent
Moti Enterprises, Inc.
11177 E. Seven Mile Rd.
Detroit,  MI  48234
Correspondent Contact MOTI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/04/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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