The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd. with the FDA for Sonicaid Fm820 And Fm830 Encore.
| Device ID | K090285 |
| 510k Number | K090285 |
| Device Name: | SONICAID FM820 AND FM830 ENCORE |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Wales, GB Cf24 5hn |
| Contact | Graham Booth |
| Correspondent | Graham Booth HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South 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 | 2009-02-05 |
| Decision Date | 2009-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968031792 | K090285 | 000 |
| 05051968031785 | K090285 | 000 |
| 05051968029843 | K090285 | 000 |
| 05051968029836 | K090285 | 000 |
| 05051968029829 | K090285 | 000 |