FDA 510(k)

AcuSee AS-P1000 System

K-Number: K202119 · 2020-10-07

ApplicantWeipeng (Suzhou) Medical Devices Co., Ltd.

Decision Date2020-10-07

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AcuSee AS-P1000 System is the device name listed in this FDA 510(k) record. The listed applicant is Weipeng (Suzhou) Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K202119. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuSee AS-P1000 System?

AcuSee AS-P1000 System is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Weipeng (Suzhou) Medical Devices Co., Ltd.. The 510(k) number is K202119.

When did AcuSee AS-P1000 System receive FDA 510(k) clearance?

AcuSee AS-P1000 System received FDA 510(k) clearance on 2020-10-07, under 510(k) number K202119.

Who is the listed applicant for AcuSee AS-P1000 System?

The FDA 510(k) record lists Weipeng (Suzhou) Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AcuSee AS-P1000 System?

The FDA product code for AcuSee AS-P1000 System is IYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.