N9+
K-Number: K223785 · 2023-04-14
ApplicantNonagon , Ltd.
Decision Date2023-04-14
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
N9+ is the device name listed in this FDA 510(k) record. The listed applicant is Nonagon , Ltd.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) 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. The listed applicant is Nonagon , Ltd.. The 510(k) number is K223785.
When did N9+ receive FDA 510(k) clearance?
N9+ received FDA 510(k) clearance on 2023-04-14, under 510(k) number K223785.
Who is the listed applicant for N9+?
The FDA 510(k) record lists Nonagon , Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.