Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELDONCARD

K-Number: K790282 · 1979-05-04

ApplicantNordisk Infuser System
Decision Date1979-05-04
Product CodeKSZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ELDONCARD 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 1979-05-04 under 510(k) number K790282. The device is classified under product code KSZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELDONCARD?

ELDONCARD is a medical device that received FDA 510(k) clearance on 1979-05-04. The listed applicant is Nordisk Infuser System. The 510(k) number is K790282.

When did ELDONCARD receive FDA 510(k) clearance?

ELDONCARD received FDA 510(k) clearance on 1979-05-04, under 510(k) number K790282.

Who is the listed applicant for ELDONCARD?

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 ELDONCARD?

The FDA product code for ELDONCARD is KSZ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K860492NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE

Related Devices (Code: KSZ)

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.

K810899TECHNICON AUTOGROUPER 16-C SYSTEMTechnicon Instruments Corp.K771098BLOOD GROUPING SYS., BG-9Technicon Instruments Corp.K770185RH CONTROL DILUENTBd Becton Dickinson Vacutainer Systems Preanalytic

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.

↑