Novaerus NV1050
K-Number: K200321 · 2020-12-28
ApplicantNovaerus Us, Inc.
Decision Date2020-12-28
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Novaerus NV1050 is a medical device manufactured by Novaerus Us, Inc.. It received FDA 510(k) clearance on 2020-12-28 under approval number K200321. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Novaerus NV1050?
Novaerus NV1050 is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Novaerus Us, Inc.. The 510(k) number is K200321.
When was Novaerus NV1050 approved by the FDA?
Novaerus NV1050 received FDA 510(k) clearance on 2020-12-28, under approval number K200321.
What company makes Novaerus NV1050?
Novaerus NV1050 is manufactured by Novaerus Us, Inc..
What is the FDA product code for Novaerus NV1050?
The FDA product code for Novaerus NV1050 is FRF.
Related Devices (Code: FRF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.