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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 K032955
Device Name AUTOMOVE, MODEL AM800
Applicant
Danmeter A/S
Kildemosevej 13
Odense C,  DK DK-5000
Applicant Contact HANNE NIELSEN
Correspondent
Danmeter A/S
Kildemosevej 13
Odense C,  DK DK-5000
Correspondent Contact HANNE NIELSEN
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
HCC  
Date Received09/22/2003
Decision Date 12/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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