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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K914231
Device Name ELPHA 2000
Applicant
Biometer Intl. A/S
21 A/ Hans Egedesvej
Dk- - 5210 Odense Nv
Denmark,  DK
Applicant Contact FLEMMING HIMMELSTRUP
Correspondent
Biometer Intl. A/S
21 A/ Hans Egedesvej
Dk- - 5210 Odense Nv
Denmark,  DK
Correspondent Contact FLEMMING HIMMELSTRUP
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/20/1991
Decision Date 05/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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