K914544 is an FDA 510(k) clearance for the BD6000 THE OPTIMA & BD5000 BIRTHING BED. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).
Submitted by Lic Care, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 24, 1993, 776 days after receiving the submission on October 10, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K914544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1991 |
| Decision Date | November 24, 1993 |
| Days to Decision | 776 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNC — Table, Obstetric (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |