K912139 is an FDA 510(k) clearance for the MODEL 704. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 25, 1992, 316 days after receiving the submission on May 14, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K912139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1991 |
| Decision Date | March 25, 1992 |
| Days to Decision | 316 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 |