K061640 is an FDA 510(k) clearance for the INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on July 27, 2006, 45 days after receiving the submission on June 12, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K061640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2006 |
| Decision Date | July 27, 2006 |
| Days to Decision | 45 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 |