The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3.
| Device ID | K173042 |
| 510k Number | K173042 |
| Device Name: | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 |
| Classification | System, Monitoring, Perinatal |
| Applicant | Edan Instruments, Inc #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District Shenzhen, CN 518122 |
| Contact | Alice Yang |
| Correspondent | Alice Yang Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, CA 94089 |
| Product Code | HGM |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | HGL |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413807242 | K173042 | 000 |