Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Edan Instruments, Inc

The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Acclarix Lx8 Diagnostic Ultrasound System, Acclarix Ax8 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK180862
510k NumberK180862
Device Name:Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Edan Instruments, Inc #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactAlice Yang
CorrespondentAlice Yang
Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale,  CA  94089
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-02
Decision Date2018-05-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413811867 K180862 000
06944413809024 K180862 000
06944413809031 K180862 000
06944413809055 K180862 000
06944413809062 K180862 000
06944413811706 K180862 000
06944413811713 K180862 000
06944413811720 K180862 000
06944413811737 K180862 000
06944413811812 K180862 000
06944413808997 K180862 000

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