FDA 510(k)

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

K-Number: K240189 · 2025-03-26

ApplicantMde Orvosbiológiai Kutató, Fejleszto,

Decision Date2025-03-26

Product CodeJXE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NM-01/CPT neurometer (NM-01/CPT) is the device name listed in this FDA 510(k) record. The listed applicant is Mde Orvosbiológiai Kutató, Fejleszto,. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K240189. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

NM-01/CPT neurometer (NM-01/CPT) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Mde Orvosbiológiai Kutató, Fejleszto,. The 510(k) number is K240189.

When did NM-01/CPT neurometer (NM-01/CPT) receive FDA 510(k) clearance?

NM-01/CPT neurometer (NM-01/CPT) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K240189.

Who is the listed applicant for NM-01/CPT neurometer (NM-01/CPT)?

The FDA 510(k) record lists Mde Orvosbiológiai Kutató, Fejleszto, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NM-01/CPT neurometer (NM-01/CPT)?

The FDA product code for NM-01/CPT neurometer (NM-01/CPT) is JXE.

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Official Source

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