Palm Bladder Scanner - PBSV7.1

System, Imaging, Pulsed Echo, Ultrasonic

Mianyang Meike Electronic Equipment Co., Ltd.

The following data is part of a premarket notification filed by Mianyang Meike Electronic Equipment Co., Ltd. with the FDA for Palm Bladder Scanner - Pbsv7.1.

Pre-market Notification Details

Device IDK210591
510k NumberK210591
Device Name:Palm Bladder Scanner - PBSV7.1
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Mianyang Meike Electronic Equipment Co., Ltd. No., 63, Yinping Road, Longmen Town, Fucheng District, Mianyang. Sichuan Mianyang,  CN 621000
ContactWenjun Zhao
CorrespondentHelen Nan
Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou,  CN 325000
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-06-09

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