MD-2300S Ultrasonic A/B Scanner For Ophthalmology

System, Imaging, Pulsed Echo, Ultrasonic

MEDA CO.,LTD

The following data is part of a premarket notification filed by Meda Co.,ltd with the FDA for Md-2300s Ultrasonic A/b Scanner For Ophthalmology.

Pre-market Notification Details

Device IDK152318
510k NumberK152318
Device Name:MD-2300S Ultrasonic A/B Scanner For Ophthalmology
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDA CO.,LTD F2C,F3D,F4C,F5,F6C,BLDG C2,Xinmao Science Skill Park Huayuan Ind. Area Tianjin,  CN 300384
ContactYusheng Zhang
CorrespondentKai Chen
Medtech International, Inc. 13505 Broadfield Drive Potomac,  MD  20854
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-17
Decision Date2015-11-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.