The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Sd1 Ultrasonic Pocket Doppler.
| Device ID | K172780 |
| 510k Number | K172780 |
| Device Name: | SD1 Ultrasonic Pocket Doppler |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | Edan Instruments Inc #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518067 |
| Contact | Alice Yang |
| Correspondent | Alice Yang Edan Medical Edan Instruments, Inc #15 Jinhui Road,Jinsha Community Kengzi Sub-district,pingshan District, CN |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2018-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413808751 | K172780 | 000 |