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FDA 510(k)

N9+

K-Number: K223785 · 2023-04-14

ApplicantNonagon , Ltd.
Decision Date2023-04-14
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

N9+ is a medical device manufactured by Nonagon , Ltd.. It received FDA 510(k) clearance on 2023-04-14 under approval number K223785. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N9+?

N9+ is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by Nonagon , Ltd.. The 510(k) number is K223785.

When was N9+ approved by the FDA?

N9+ received FDA 510(k) clearance on 2023-04-14, under approval number K223785.

What company makes N9+?

N9+ is manufactured by Nonagon , Ltd..

What is the FDA product code for N9+?

The FDA product code for N9+ is DQD.

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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.

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