AcuSee AS-P1000 System

System, Imaging, Pulsed Echo, Ultrasonic

Weipeng (Suzhou) Medical Devices Co., Ltd.

The following data is part of a premarket notification filed by Weipeng (suzhou) Medical Devices Co., Ltd. with the FDA for Acusee As-p1000 System.

Pre-market Notification Details

Device IDK202119
510k NumberK202119
Device Name:AcuSee AS-P1000 System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Weipeng (Suzhou) Medical Devices Co., Ltd. Unit 207, Building B2, Biobay, 218 Xinghu St., Suzhou Industrial Park Suzhou,  CN 215123
ContactBin Yang
CorrespondentGeetha Rao
Springborne Life Sciences 750 Menlo Avenue, Suite 200 Menlo Park,  CA  94025
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-30
Decision Date2020-10-07

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