The following data is part of a premarket notification filed by Raumedic Ag with the FDA for Raumedic Icp Monitoring System.
Device ID | K112017 |
510k Number | K112017 |
Device Name: | RAUMEDIC ICP MONITORING SYSTEM |
Classification | Device, Monitoring, Intracranial Pressure |
Applicant | RAUMEDIC AG HERRMANN-STAUDINGER-STR. 2 Helmbrechts, DE D 95233 |
Contact | Reiner Thiem |
Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | GWM |
CFR Regulation Number | 882.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-07-14 |
Decision Date | 2011-10-11 |
Summary: | summary |