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 HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
OLAF TEICHERT |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 07/14/2011 |
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
|
|
|