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)

EZMANAGER PLUS

K-Number: K022394 · 2003-06-05

ApplicantAnimas Corp.
Decision Date2003-06-05
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZMANAGER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2003-06-05 under 510(k) number K022394. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZMANAGER PLUS?

EZMANAGER PLUS is a medical device that received FDA 510(k) clearance on 2003-06-05. The listed applicant is Animas Corp.. The 510(k) number is K022394.

When did EZMANAGER PLUS receive FDA 510(k) clearance?

EZMANAGER PLUS received FDA 510(k) clearance on 2003-06-05, under 510(k) number K022394.

Who is the listed applicant for EZMANAGER PLUS?

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

What is the FDA product code for EZMANAGER PLUS?

The FDA product code for EZMANAGER PLUS is LZG.

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 Animas Corp. 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.

K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEMK080587EZ MANAGER MAX DIABETES MANAGEMENT SOFTWAREK063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWAREK042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMPK032257MODEL IR 1200 INSULIN PUMPK021700ANIMUS EZSERTER INFUSION SET INSERTER

View all 10 devices →

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, 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.

↑