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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 K974255
Device Name CD-R STATION AND VRS-2000
Applicant
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Applicant Contact JAMES RIEDL
Correspondent
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Correspondent Contact JAMES RIEDL
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/13/1997
Decision Date 01/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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