The following data is part of a premarket notification filed by Raumedic Ag with the FDA for Raumedic-pto-monitoring-system.
| Device ID | K130529 |
| 510k Number | K130529 |
| Device Name: | RAUMEDIC-PTO-MONITORING-SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | RAUMEDIC AG HERRMANN-STAUDINGER-STR. 2 Helmbrechts, DE 95233 |
| Contact | Reiner Thiem |
| Correspondent | Norbert Stuiber 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 | 2013-03-01 |
| Decision Date | 2013-10-25 |
| Summary: | summary |