The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Acclarix Ax8 Diagnostic Ultrasound System / Acclarix Lx9 Series Diagnostic Ultrasound System.
| Device ID | K192879 |
| 510k Number | K192879 |
| Device Name: | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Edan Instruments, Inc #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District Shenzhen, CN 518122 |
| Contact | Melody Huang |
| Correspondent | Melody Huang 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 | 2019-09-30 |
| Decision Date | 2020-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413811959 | K192879 | 000 |
| 06944413811782 | K192879 | 000 |
| 06944413811775 | K192879 | 000 |
| 06944413811768 | K192879 | 000 |