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FDA 510(k)

NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE

K-Number: K860492 · 1986-02-19

ApplicantNordisk Infuser System
Decision Date1986-02-19
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Nordisk Infuser System. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K860492. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE?

NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Nordisk Infuser System. The 510(k) number is K860492.

When did NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE receive FDA 510(k) clearance?

NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE received FDA 510(k) clearance on 1986-02-19, under 510(k) number K860492.

Who is the listed applicant for NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE?

The FDA 510(k) record lists Nordisk Infuser System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE?

The FDA product code for NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE is FRN.

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Other records listing Nordisk Infuser System 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.

K790282ELDONCARD

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

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