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510(k) K002992

Device
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
510(k) number
K002992
Product code
IKT  
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-15
Date received
2000-09-25
Regulation
890.1385
Classification name
Electrode, Needle, Diagnostic Electromyograph
Medical specialty
Physical Medicine
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TOVE KJAER
Address
16-18 Tonsbakken Skovlunde DK DK-2740 DK-2740

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IKT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed Europe2026-03-15
K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited2018-06-29
K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited2017-03-02
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.2016-06-03
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mmNatus Manufacturing Limited2015-08-28
K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC2012-06-22
K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.2011-08-12
K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESCarefusion 209, Inc.2011-06-17
K092973DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLEBionen S.A.S.2010-10-07
K093825AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODEAmbu A/S2010-01-13
K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,Spes Medica Srl2009-08-11
K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RRhythmlink International, LLC2009-06-23
K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RRhythmlink International, LLC2009-06-23
K080914ULTRASHARP CONCENTRIC NEEDLESRochester Electro Medical, Inc.2008-07-15
K071186MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODEAmbu A/S2007-07-30

Legacy Summary#

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FDA Review#

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