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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K003688
Device Name VIEW READING STATION
Applicant
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Applicant Contact JEAN-LUC DES GROSEILLIERS
Correspondent
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Correspondent Contact JEAN-LUC DES GROSEILLIERS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/30/2000
Decision Date 01/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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