Decision Date2021-06-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NovoFine is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K210258. 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?
NovoFine is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K210258.
When did NovoFine receive FDA 510(k) clearance?
NovoFine received FDA 510(k) clearance on 2021-06-23, under 510(k) number K210258.
Who is the listed applicant for NovoFine?
The FDA 510(k) record lists Novo Nordisk, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NovoFine?
The FDA product code for NovoFine is FMI.
Other records listing Novo Nordisk, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.