K152670 is an FDA 510(k) clearance for the DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on January 22, 2016, 127 days after receiving the submission on September 17, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K152670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2015 |
| Decision Date | January 22, 2016 |
| Days to Decision | 127 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 |