K884868 is an FDA 510(k) clearance for the OBSTETRICAL SAFETY SYSTEM. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).
Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on March 1, 1989, 100 days after receiving the submission on November 21, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K884868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1988 |
| Decision Date | March 01, 1989 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | KNC — Table, Obstetric (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |