FDA.reportPublic FDA data

510(k) K935017

Device
TD50 ELECTROMYOGRAPH
Applicant
MEDELEC INTL. CORP.
510(k) number
K935017
Product code
JXE  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-28
Date received
1993-10-19
Regulation
882.1550
Classification name
Device, Nerve Conduction Velocity Measurement
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
J. B. HOLLOWAY
Address
Manor Way Old Woking, Surrey Gu22 9ju England GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JXE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,2025-03-26
K190536Mediracer NCSMediracer OY2019-09-25
K070109NEUROMETRIX ADVANCENeurometrix, Inc.2008-04-25
K060584NC-STATNeurometrix, Inc.2006-07-31
K053058XLTEK NEUROPATH, MODEL PK1070Excel Tech. , Ltd.2006-02-07
K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, Inc.2005-10-27
K041320MODIFICATION TO NC-STATNeurometrix, Inc.2004-08-12
K013459MODIFICATION OF NC-STATNeurometrix, Inc.2002-01-17
K012069MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENTNeurotron Medical, Inc.2001-08-01
K003508NC-STATNeurometrix, Inc.2001-01-17
K001692NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8Neurosoft, Inc.2000-11-24
K000565MODIFICATION TO NC-STATNeurometrix, Inc.2000-06-27
K982359NC-STATNeurometrix, Inc.1998-10-02
K963208NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)Neurotron Medical1997-07-14
K935298INSTA-NERVE(TM) NERVE CONDUCTION MONITORInsta Nerve Canada, Inc.1994-08-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases