K935098 is an FDA 510(k) clearance for the BABY BOARD, a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Sentry Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on February 15, 1994, 113 days after receiving the submission on October 25, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3910.
| 510(k) Number | K935098 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 1993 |
| Decision Date | February 15, 1994 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BTX — Board, Arm (with Cover), Sterile |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.3910 |