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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K921278
Device Name M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION
Applicant
Metecon, Inc.
600 Hobart St.
Menlo Park,  CA  94025
Applicant Contact PETER WASOWSKI
Correspondent
Metecon, Inc.
600 Hobart St.
Menlo Park,  CA  94025
Correspondent Contact PETER WASOWSKI
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/17/1992
Decision Date 05/18/1992
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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