Qorda QD1

Cleaner, Air, Medical Recirculating

Winix Inc.

The following data is part of a premarket notification filed by Winix Inc. with the FDA for Qorda Qd1.

Pre-market Notification Details

Device IDK220990
510k NumberK220990
Device Name:Qorda QD1
ClassificationCleaner, Air, Medical Recirculating
Applicant Winix Inc. 80-13, Sujeong-ro, Jangan-myeon Hwaseong-si,  KR 18583
ContactDaewoon Kang
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeFRF  
CFR Regulation Number880.5045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-09-14

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