K790920 is an FDA 510(k) clearance for the INTRACRANIAL PRESSURE MONITORING. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on August 3, 1979, 86 days after receiving the submission on May 9, 1979.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K790920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1979 |
| Decision Date | August 03, 1979 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | GWM - Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |