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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 a medical device manufactured by Weipeng (Suzhou) Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2020-10-07 under approval 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. It is manufactured by Weipeng (Suzhou) Medical Devices Co., Ltd.. The 510(k) number is K202119.

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

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

What company makes AcuSee AS-P1000 System?

AcuSee AS-P1000 System is manufactured by Weipeng (Suzhou) Medical Devices Co., Ltd..

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.

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