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 | K162055 |
510k Number | K162055 |
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 | Alice Yang |
Correspondent | Doug Worth Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, CA 94089 |
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 | 2016-07-25 |
Decision Date | 2017-01-31 |
Summary: | summary |