NM-01/CPT neurometer (NM-01/CPT)— 510(k) K240189

Name: FDA 510(k) clearance K240189
Creator: U.S. Food and Drug Administration
Published: 2025-03-26

Substantially Equivalent

Mde Orvosbiológiai Kutató, Fejleszto,

FDA 510(k) clearance K240189 for NM-01/CPT neurometer (NM-01/CPT), Substantially Equivalent on 2025-03-26. Applicant: Mde Orvosbiológiai Kutató, Fejleszto,. Device class: 2.

Clearance details

Applicant: Mde Orvosbiológiai Kutató, Fejleszto,
Product code: Code JXE
Device class: Class 2
Regulation: 21 CFR 882.1550
Advisory panel: Neurology
Date received: 2024-01-24
Decision date: 2025-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budapest, HU

Download summary PDF View on FDA.gov ↗

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