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)

IKAROS

K-Number: K940240 · 1995-02-24

ApplicantMetasystems GmbH
Decision Date1995-02-24
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IKAROS is the device name listed in this FDA 510(k) record. The listed applicant is Metasystems GmbH. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K940240. The device is classified under product code LNJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IKAROS?

IKAROS is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Metasystems GmbH. The 510(k) number is K940240.

When did IKAROS receive FDA 510(k) clearance?

IKAROS received FDA 510(k) clearance on 1995-02-24, under 510(k) number K940240.

Who is the listed applicant for IKAROS?

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

What is the FDA product code for IKAROS?

The FDA product code for IKAROS is LNJ.

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

Related Devices (Code: LNJ)

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.

K050236FISHVIEWApplied Spectral Imaging , Ltd.K012103BANDVIEW SYSTEMApplied Spectral Imaging , Ltd.K912085ACLAIMS-ISW-TechnologyK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.Applied Imaging Corp.K895095AKS IIAmoco Technology Co.K872755KARYOTEC 100Amcor Electronics, Ltd.

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.

↑