AcuSee AS-P1000 System

FDA 510(k) K202119 · Weipeng (Suzhou) Medical Devices Co., Ltd.

Substantially Equivalent

510(k) numberK202119

Submission

Device name
AcuSee AS-P1000 System
Applicant
Weipeng (Suzhou) Medical Devices Co., Ltd.
Suzhou, CN
Received
July 30, 2020
Decision date
October 7, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was AcuSee AS-P1000 System cleared by the FDA?

AcuSee AS-P1000 System (K202119) received a 510(k) decision of Substantially Equivalent on October 7, 2020, 69 days after the submission was received.

What is the product code of K202119?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.