NovoFine® Plus
K-Number: K231255 · 2023-08-25
ApplicantNovo Nordisk, Inc.
Decision Date2023-08-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NovoFine® Plus is a medical device manufactured by Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2023-08-25 under approval number K231255. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovoFine® Plus?
NovoFine® Plus is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Novo Nordisk, Inc.. The 510(k) number is K231255.
When was NovoFine® Plus approved by the FDA?
NovoFine® Plus received FDA 510(k) clearance on 2023-08-25, under approval number K231255.
What company makes NovoFine® Plus?
NovoFine® Plus is manufactured by Novo Nordisk, Inc..
What is the FDA product code for NovoFine® Plus?
The FDA product code for NovoFine® Plus is FMI.
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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.