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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Novaerus Us, Inc.. It received FDA 510(k) clearance on 2020-12-28 under 510(k) 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. The listed applicant is Novaerus Us, Inc.. The 510(k) number is K200321.

When did Novaerus NV1050 receive FDA 510(k) clearance?

Novaerus NV1050 received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200321.

Who is the listed applicant for Novaerus NV1050?

The FDA 510(k) record lists Novaerus Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Novaerus NV1050?

The FDA product code for Novaerus NV1050 is FRF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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