K003759 is an FDA 510(k) clearance for the AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Aesculap, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on June 28, 2001, 204 days after receiving the submission on December 6, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K003759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2000 |
| Decision Date | June 28, 2001 |
| Days to Decision | 204 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 |