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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 K990759
Device Name VIEW COM
Applicant
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Applicant Contact PASCAL M KAUFMANN
Correspondent
Electromed Intl., Ltd.
310 Industrial Blvd.
St-Eustache, Quebec,  CA J7R 5R4
Correspondent Contact PASCAL M KAUFMANN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/1999
Decision Date 04/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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