K983799 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on January 26, 1999, 90 days after receiving the submission on October 28, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K983799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1998 |
| Decision Date | January 26, 1999 |
| Days to Decision | 90 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 |