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510(k) K220990

Qorda QD1 by Winix, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2022
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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