K950889 is an FDA 510(k) clearance for the ADEL 5000. This device is classified as a Table, Obstetrical, Ac-powered (and Accessories) (Class II - Special Controls, product code HDD).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on October 16, 1995, 230 days after receiving the submission on February 28, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K950889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1995 |
| Decision Date | October 16, 1995 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDD — Table, Obstetrical, Ac-powered (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |