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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K070818
Device Name MEDILOGAR4, MEDILOGAR12
Applicant
Tom Medical Entwicklungs GmbH
Anzengrubergasse 8
Graz,  AT A-8010
Applicant Contact THOMAS HASIBA
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/26/2007
Decision Date 04/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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