Acclarix LX8 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.

Pre-market Notification Details

Device IDK162055
510k NumberK162055
Device Name:Acclarix LX8 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant EDAN INSTRUMENTS INC 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK NANHAI RD 1019# Shenzhen,  CN 518067
ContactAlice Yang
CorrespondentDoug Worth
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 Received2016-07-25
Decision Date2017-01-31
Summary:summary

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