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FDA 510(k)

NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE

K-Number: K921908 · 1993-06-29

ApplicantNovo Nordisk Pharmaceuticals, Inc.
Decision Date1993-06-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE 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 1993-06-29 under 510(k) number K921908. 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 NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE?

NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Novo Nordisk Pharmaceuticals, Inc.. The 510(k) number is K921908.

When did NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE receive FDA 510(k) clearance?

NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE received FDA 510(k) clearance on 1993-06-29, under 510(k) number K921908.

Who is the listed applicant for NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE?

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 NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE?

The FDA product code for NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE is FMF.

Related Clinical Trials

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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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.

K942159NOVOPEN 1.5

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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