• 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 nystagmograph
510(k) Number K192186
Device Name I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
Neurolign USA, LLC
128 Gamma Drive
Pittsburgh,  PA  15238
Applicant Contact Aura Kullmann
Neurolign USA, LLC
128 Gamma Drive
Pittsburgh,  PA  15238
Correspondent Contact Aura Kullmann
Regulation Number882.1460
Classification Product Code
Date Received08/12/2019
Decision Date 11/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01832714
Reviewed by Third Party No
Combination Product No