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FDA 510(k)

NOVOPEN 1.5

K-Number: K942159 · 1995-04-26

ApplicantNovo Nordisk Pharmaceuticals, Inc.
Decision Date1995-04-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVOPEN 1.5 is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1995-04-26 under 510(k) number K942159. 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 NOVOPEN 1.5?

NOVOPEN 1.5 is a medical device that received FDA 510(k) clearance on 1995-04-26. The listed applicant is Novo Nordisk Pharmaceuticals, Inc.. The 510(k) number is K942159.

When did NOVOPEN 1.5 receive FDA 510(k) clearance?

NOVOPEN 1.5 received FDA 510(k) clearance on 1995-04-26, under 510(k) number K942159.

Who is the listed applicant for NOVOPEN 1.5?

The FDA 510(k) record lists Novo Nordisk Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVOPEN 1.5?

The FDA product code for NOVOPEN 1.5 is FMF.

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Other records listing Novo Nordisk Pharmaceuticals, 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.

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Related Devices (Code: FMF)

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

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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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