The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum.
| Device ID | K200975 |
| 510k Number | K200975 |
| Device Name: | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum |
| Classification | System, Monitoring, Perinatal |
| Applicant | Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Contact | Steve Monks |
| Correspondent | Steve Monks Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-13 |
| Decision Date | 2020-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968041234 | K200975 | 000 |
| 05051968044266 | K200975 | 000 |
| 05051968044259 | K200975 | 000 |
| 05051968044242 | K200975 | 000 |
| 05051968042972 | K200975 | 000 |
| 05051968047045 | K200975 | 000 |
| 05051968047038 | K200975 | 000 |
| 05051968047021 | K200975 | 000 |
| 05051968047144 | K200975 | 000 |
| 05051968047151 | K200975 | 000 |
| 05051968047090 | K200975 | 000 |
| 05051968047120 | K200975 | 000 |
| 05051968047113 | K200975 | 000 |
| 05051968044273 | K200975 | 000 |
| 05051968044280 | K200975 | 000 |
| 05051968044297 | K200975 | 000 |
| 05051968042071 | K200975 | 000 |
| 05051968044037 | K200975 | 000 |
| 05051968044020 | K200975 | 000 |
| 05051968032522 | K200975 | 000 |
| 05051968032515 | K200975 | 000 |
| 05051968032508 | K200975 | 000 |
| 05051968032492 | K200975 | 000 |
| 05051968032485 | K200975 | 000 |
| 00505196832539 | K200975 | 000 |
| 05051968032539 | K200975 | 000 |
| 05051968044310 | K200975 | 000 |
| 05051968044303 | K200975 | 000 |
| 05051968047106 | K200975 | 000 |