K103545 is an FDA 510(k) clearance for the BT-350. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Bistos Co., Ltd. (Brooklyn, US). The FDA issued a Cleared decision on May 13, 2011, 162 days after receiving the submission on December 2, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K103545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2010 |
| Decision Date | May 13, 2011 |
| Days to Decision | 162 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 |