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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 K130529
Device Name RAUMEDIC-PTO-MONITORING-SYSTEM
Applicant
RAUMEDIC AG
HERRMANN-STAUDINGER-STR. 2
HELMBRECHTS,  DE 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 Received03/01/2013
Decision Date 10/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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