The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Acclarix Lx8 Diagnostic Ultrasound System.
| Device ID | K160790 |
| 510k Number | K160790 |
| Device Name: | Acclarix LX8 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Edan Instruments Inc 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2016-03-22 |
| Decision Date | 2016-04-04 |
| Summary: | summary |