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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2022-02-16 under 510(k) 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. The listed applicant is U&I Corporation. The 510(k) number is K220147.

When did Aspiron S ACP System receive FDA 510(k) clearance?

Aspiron S ACP System received FDA 510(k) clearance on 2022-02-16, under 510(k) number K220147.

Who is the listed applicant for Aspiron S ACP System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspiron S ACP System?

The FDA product code for Aspiron S ACP System is KWQ.

Other records listing U&I Corporation as applicant

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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