RAUMEDIC ICP MONITORING SYSTEM


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
Regulation Number 882.1620
Classification Product Code
GWM  
Date Received 07/14/2011
Decision Date 10/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No