510(k) clearances

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

Mde Orvosbiológiai Kutató, Fejleszto, · Neurology

K240189Substantially EquivalentTraditionalJXE
Open FDA's page for this record
Third party flag
N
City
Budapest
Advisory committee description
Neurology
Address 1
Gyártó Korlátolt Felelosségu Társaság
Address 2
Podmaniczky U. 87
Statement or summary
Summary
Product code
JXE
Zip code
1064
Applicant
Mde Orvosbiológiai Kutató, Fejleszto,
Decision date
2025-03-26
Decision code
SESE
Country code
HU
Device name
NM-01/CPT neurometer (NM-01/CPT)
Advisory committee
NE
Contact
Aba Tomjanovich
K number
K240189
Date received
2024-01-24
Review advisory committee
NE
Postal code
1064
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Device, Nerve Conduction Velocity Measurement
Medical specialty description
Neurology
Regulation number
882.1550
Device class
2
Registration number
8030229, 3008881376, 2184161, 9611896, 2080783, 3006697681, 3011766844, 3012182497, 3001687738, 3024996452, 3017448360, 8021774, 3020018, 3016852448, 3005581270, 3006418479, 3013501110, 2023374, 2022388, 1319639, 3010611950, 3008773490, 3013246402, 3011790297, 3007962724, 9611252, 2183456, 1067162
FEI number
2183456, 3008881376, 3002807739, 2080783, 3006697681, 3011766844, 3012182497, 3001687738, 3024996452, 3017448360, 3002807720, 3020018, 3016852448, 3003831320, 3005581270, 3002808356, 3006418479, 3013501110, 2023374, 2022388, 3010611950, 3008773490, 3013246402, 3011790297, 1000138054, 3007962724, 1000139867, 3002957361
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.