K200975 is an FDA 510(k) clearance for the Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Huntleigh Healthcare Limited (Cardiff, GB). The FDA issued a Cleared decision on June 24, 2020, 72 days after receiving the submission on April 13, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K200975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2020 |
| Decision Date | June 24, 2020 |
| Days to Decision | 72 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 |