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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K103206
Device Name RAUMEDIC- ICP-MONITORING SYSTEM
Applicant
Raumedic AG
Herrmann-Staudinger-Str. 2
Helmbrechts,  DE D 95233
Applicant Contact REINER THIEM
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact NORBERT STUIBER
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/01/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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