K240189

NM-01/CPT neurometer (NM-01/CPT)

510(k) number
K240189
Device name
NM-01/CPT neurometer (NM-01/CPT)
Applicant
Mde Orvosbiológiai Kutató, Fejleszto, HU
Product code
JXE — Device, Nerve Conduction Velocity Measurement
Decision date
2025-03-26
Date received
2024-01-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K240189.pdf

Official FDA record: K240189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.