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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 K112017
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 Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact OLAF TEICHERT
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/14/2011
Decision Date 10/11/2011
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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