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510(k) K240189

Device
NM-01/CPT neurometer (NM-01/CPT)
Applicant
Mde Orvosbiológiai Kutató, Fejleszto,
510(k) number
K240189
Product code
JXE
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-26
Date received
2024-01-24
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
Summary
Third party reviewed
N

Applicant Contact#

Contact
Aba Tomjanovich
Address
Gyártó Korlátolt Felelosségu Társaság Podmaniczky U. 87 Budapest HU 1064 1064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K935017TD50 ELECTROMYOGRAPHMedelec Intl. Corp.1994-07-28