Qorda QD1— 510(k) K220990

Substantially Equivalent

Winix, Inc.

FDA 510(k) clearance K220990 for Qorda QD1, Substantially Equivalent on 2022-09-14. Applicant: Winix, Inc.. Device class: 2.

Clearance details

Applicant: Winix, Inc.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 2022-04-04
Decision date: 2022-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.