K130529 is an FDA 510(k) clearance for the RAUMEDIC-PTO-MONITORING-SYSTEM. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Raumedic AG (Helmbrechts, DE). The FDA issued a Cleared decision on October 25, 2013, 238 days after receiving the submission on March 1, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K130529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2013 |
| Decision Date | October 25, 2013 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWM — Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |