The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Sonicaid Freedom Wireless Fetal Monitoring System.
| Device ID | K132650 |
| 510k Number | K132650 |
| Device Name: | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales, GB Cf24 5hn |
| Contact | Laura Garcia Deacon |
| Correspondent | Laura Garcia Deacon HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales, 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 | 2013-08-26 |
| Decision Date | 2014-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968032416 | K132650 | 000 |
| 05051968032409 | K132650 | 000 |
| 05051968032133 | K132650 | 000 |
| 05051968042057 | K132650 | 000 |