The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System.
| Device ID | K192791 |
| 510k Number | K192791 |
| Device Name: | Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Contact | Stella Guo |
| Correspondent | Stella Guo Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413812703 | K192791 | 000 |
| 06944413811461 | K192791 | 000 |
| 06944413811478 | K192791 | 000 |
| 06944413811485 | K192791 | 000 |
| 06944413811492 | K192791 | 000 |
| 06944413811508 | K192791 | 000 |
| 06944413811522 | K192791 | 000 |
| 06944413811546 | K192791 | 000 |
| 06944413811560 | K192791 | 000 |
| 06944413811584 | K192791 | 000 |
| 06944413811744 | K192791 | 000 |
| 06944413811751 | K192791 | 000 |
| 06944413812185 | K192791 | 000 |
| 06944413811454 | K192791 | 000 |