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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K875341
Device Name EDEC 60 R/F
Applicant
Electromed Intl., Ltd.
395 Boul. Industriel
St-Eustache, Quebec
Canada,  CA J7R 5R3
Applicant Contact RAMIREZ, ENG
Correspondent
Electromed Intl., Ltd.
395 Boul. Industriel
St-Eustache, Quebec
Canada,  CA J7R 5R3
Correspondent Contact RAMIREZ, ENG
Regulation Number892.1700
Classification Product Code
IZO  
Date Received12/30/1987
Decision Date 02/01/1988
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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