K142799 is an FDA 510(k) clearance for the Model BT-220L and BT-220C. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Bistos Co., Ltd. (Ramsey, US). The FDA issued a Cleared decision on July 9, 2015, 283 days after receiving the submission on September 29, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K142799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2014 |
| Decision Date | July 09, 2015 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGM - System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |