FDA.reportPublic FDA data

Neurolign USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25199452519945Neurolign USA, LLC1N2020-04-25128 GAMMA DR. Blawnox PA US 15238

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2358241685107502K781268CHAIR, VESTIBULAR, ROTARY, COMPUT.LXV1978-08-14
2358241324832802K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographGWN2019-11-29
2358241277377657K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking SystemGWN2018-07-24
2358241644890847K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)GWN2017-11-22
2358241398089501K143607I-Portal NOTC, VNG and VOGGWN2015-07-08
2358241224876806K083603I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOLGWN2009-08-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWN52019-11-29
LXV11978-08-14

PMN#