MD-320W Ultrasound Biomicroscope

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-320w Ultrasound Biomicroscope.

Pre-market Notification Details

Device IDK213070
510k NumberK213070
Device Name:MD-320W Ultrasound Biomicroscope
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Meda Co., LTD F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin,  CN 300384
ContactLinda Zhang
CorrespondentLinda Zhang
Meda Co., LTD F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin,  CN 300384
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-23
Decision Date2021-11-18

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