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FDA 510(k)

Qorda QD1

K-Number: K220990 · 2022-09-14

ApplicantWinix, Inc.
Decision Date2022-09-14
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Qorda QD1 is the device name listed in this FDA 510(k) record. The listed applicant is Winix, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K220990. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qorda QD1?

Qorda QD1 is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Winix, Inc.. The 510(k) number is K220990.

When did Qorda QD1 receive FDA 510(k) clearance?

Qorda QD1 received FDA 510(k) clearance on 2022-09-14, under 510(k) number K220990.

Who is the listed applicant for Qorda QD1?

The FDA 510(k) record lists Winix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Qorda QD1?

The FDA product code for Qorda QD1 is FRF.

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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

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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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