RAUMEDIC ICP MONITORING SYSTEM

Device, Monitoring, Intracranial Pressure

RAUMEDIC AG

The following data is part of a premarket notification filed by Raumedic Ag with the FDA for Raumedic Icp Monitoring System.

Pre-market Notification Details

Device IDK112017
510k NumberK112017
Device Name:RAUMEDIC ICP MONITORING SYSTEM
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant RAUMEDIC AG HERRMANN-STAUDINGER-STR. 2 Helmbrechts,  DE D 95233
ContactReiner Thiem
CorrespondentOlaf Teichert
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-07-14
Decision Date2011-10-11
Summary:summary

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