Aspiron S ACP System
K-Number: K220147 · 2022-02-16
ApplicantU&I Corporation
Decision Date2022-02-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Aspiron S ACP System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2022-02-16 under approval number K220147. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aspiron S ACP System?
Aspiron S ACP System is a medical device that received FDA 510(k) clearance on 2022-02-16. It is manufactured by U&I Corporation. The 510(k) number is K220147.
When was Aspiron S ACP System approved by the FDA?
Aspiron S ACP System received FDA 510(k) clearance on 2022-02-16, under approval number K220147.
What company makes Aspiron S ACP System?
Aspiron S ACP System is manufactured by U&I Corporation.
What is the FDA product code for Aspiron S ACP System?
The FDA product code for Aspiron S ACP System is KWQ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.