Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K240189
Device Name NM-01/CPT neurometer (NM-01/CPT)
Applicant
Mde Orvosbiológiai Kutató, Fejleszto,
Gyártó Korlátolt Felelosségu Társaság
Podmaniczky U. 87
Budapest,  HU 1064
Applicant Contact Aba Tomjanovich
Correspondent
Mde Orvosbiológiai Kutató, Fejleszto,
Gyártó Korlátolt Felelosségu Társaság
Podmaniczky U. 87
Budapest,  HU 1064
Correspondent Contact Aba Tomjanovich
Regulation Number882.1550
Classification Product Code
JXE  
Date Received01/24/2024
Decision Date 03/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-