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FDA 510(k)

INNOVO

K-Number: K010359 · 2001-03-14

ApplicantNovo Nordisk A/S
Decision Date2001-03-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INNOVO is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk A/S. It received FDA 510(k) clearance on 2001-03-14 under 510(k) number K010359. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVO?

INNOVO is a medical device that received FDA 510(k) clearance on 2001-03-14. The listed applicant is Novo Nordisk A/S. The 510(k) number is K010359.

When did INNOVO receive FDA 510(k) clearance?

INNOVO received FDA 510(k) clearance on 2001-03-14, under 510(k) number K010359.

Who is the listed applicant for INNOVO?

The FDA 510(k) record lists Novo Nordisk A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVO?

The FDA product code for INNOVO is FMF.

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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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