The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System, Models: Acclarix Ax3, Acclarix Ax3 Exp, Acclarix Ax3 Super, Acclarix Ax25, Acclarix Ax28, Acclarix Ax2, Acclarix Ax2 Exp, Acclarix Ax2 Super, Acclarix Ax15, Acclarix Ax18, Acclarix Lx3, Acclarix Lx3 Exp, Acclarix Lx3 Sup.
| Device ID | K202856 |
| 510k Number | K202856 |
| Device Name: | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Sup |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122 |
| Contact | Ying Dai |
| Correspondent | Ying Dai Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413813939 | K202856 | 000 |
| 06944413813342 | K202856 | 000 |
| 06944413813328 | K202856 | 000 |
| 06944413813311 | K202856 | 000 |
| 06944413813304 | K202856 | 000 |
| 06944413813298 | K202856 | 000 |