The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ultrasonic Pocket Doppler.
| Device ID | K140579 |
| 510k Number | K140579 |
| Device Name: | ULTRASONIC POCKET DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Queena Chen EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong, CN 518067 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413805620 | K140579 | 000 |
| 06944413801790 | K140579 | 000 |
| 06944413801806 | K140579 | 000 |
| 06944413801813 | K140579 | 000 |
| 06944413802032 | K140579 | 000 |
| 06944413805583 | K140579 | 000 |
| 06944413805590 | K140579 | 000 |
| 06944413805606 | K140579 | 000 |
| 06944413805613 | K140579 | 000 |
| 06944413801783 | K140579 | 000 |