The following data is part of a premarket notification filed by Winix Inc. with the FDA for Qorda Qd1.
Device ID | K220990 |
510k Number | K220990 |
Device Name: | Qorda QD1 |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | Winix Inc. 80-13, Sujeong-ro, Jangan-myeon Hwaseong-si, KR 18583 |
Contact | Daewoon Kang |
Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-04-04 |
Decision Date | 2022-09-14 |