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)

ELITE SYSTEM

K-Number: K911416 · 1991-06-06

ApplicantGfb Intl. Trading, Inc.
Decision Date1991-06-06
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELITE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gfb Intl. Trading, Inc.. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K911416. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE SYSTEM?

ELITE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Gfb Intl. Trading, Inc.. The 510(k) number is K911416.

When did ELITE SYSTEM receive FDA 510(k) clearance?

ELITE SYSTEM received FDA 510(k) clearance on 1991-06-06, under 510(k) number K911416.

Who is the listed applicant for ELITE SYSTEM?

The FDA 510(k) record lists Gfb Intl. Trading, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITE SYSTEM?

The FDA product code for ELITE SYSTEM is LXJ.

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: LXJ)

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.

K192474VERAReflexion Health, Inc.K182333VeraReflexion Health, Inc.K180880DARI HealthScientific Analytics, Inc.K171547Qualisys Clinical SystemQualisys ABK173931MindMotion(TM) GOMindmaze SAK172882UINCARE HOMEUincare Corp.

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.

↑