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NM-01/CPT Neurometer (NM-01)

by Mde Orvosbiológiai Kutató, Fejleszto,

510(k) K240189

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240189 Date26 Mar 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXE
Device Class
Class II
Regulation
21 CFR Part 882.1550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NM-01/CPT neurometer (NM-01) is a device used for nerve conduction velocity measurement, classified under the neurology medical specialty. It is a Class 2 medical device with product code JXE, designed to measure nerve conduction velocity as part of neurological assessment.

The device received FDA 510(k) clearance under K240189 on March 26, 2025, following a traditional 510(k) pathway after a 427-day review. It is substantially equivalent to a predicate device and is regulated under regulation number 882.1550. The device is manufactured by Mde Orvosbiológiai Kutató, Fejleszto, in Budapest, Hungary.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NM-01/CPT neurometer (NM-01) used for?

    The NM-01/CPT neurometer (NM-01) is used to measure nerve conduction velocity as part of neurological assessment. It falls under the neurology medical specialty and is designed specifically for this diagnostic function, helping clinicians evaluate the speed of electrical signals in nerves.

  • What regulatory pathway was used for the NM-01/CPT neurometer (NM-01)?

    The NM-01/CPT neurometer (NM-01) received FDA 510(k) clearance through a traditional pathway. It was found substantially equivalent to a predicate device under regulation number 882.1550, with clearance granted on March 26, 2025, under K240189 after a 427-day review.

  • Who manufactures the NM-01/CPT neurometer (NM-01) and where is it made?

    The NM-01/CPT neurometer (NM-01) is manufactured by Mde Orvosbiológiai Kutató, Fejleszto, located in Budapest, Hungary. The manufacturer’s address is Gyártó Korlátolt Felelosségu Társaság, Podmaniczky U. 87, Budapest, 1064, Hungary.