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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 K843443
Device Name EDEC-100
Applicant
Electromed Intl., Ltd.
38201 E. Spaulding St.
Clair Bldg.
Willoughby,  OH  44094
Applicant Contact BRUCE G LACASSE
Correspondent
Electromed Intl., Ltd.
38201 E. Spaulding St.
Clair Bldg.
Willoughby,  OH  44094
Correspondent Contact BRUCE G LACASSE
Regulation Number892.1700
Classification Product Code
IZO  
Date Received09/04/1984
Decision Date 03/01/1985
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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