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510(k) K200321

Novaerus NV1050 by Novaerus Us, Inc. — Product Code FRF

K200321 is an FDA 510(k) premarket notification submitted by Novaerus Us, Inc. for the device "Novaerus NV1050". The FDA issued a decision of Substantially Equivalent on December 28, 2020. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2020
Date Received
February 10, 2020
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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FDA data resources