K914479 is an FDA 510(k) clearance for the MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 7, 1994, 881 days after receiving the submission on October 8, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K914479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1991 |
| Decision Date | March 07, 1994 |
| Days to Decision | 881 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GWM - Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |