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)

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)

K-Number: K950314 · 1996-03-25

ApplicantDantec Medical, Inc.
Decision Date1996-03-25
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1996-03-25 under 510(k) number K950314. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)?

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) is a medical device that received FDA 510(k) clearance on 1996-03-25. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K950314.

When did DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) receive FDA 510(k) clearance?

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) received FDA 510(k) clearance on 1996-03-25, under 510(k) number K950314.

Who is the listed applicant for DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)?

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

What is the FDA product code for DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)?

The FDA product code for DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) is GXZ.

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 Dantec Medical, Inc. 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.

K960503DANTEC DUETK953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP LK932059NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

View all 25 devices →

Related Devices (Code: GXZ)

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.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLC

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.

↑