Spryson America Inc FDA Filings

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2519945	2519945	Spryson America Inc	1	N	2026-01-01	201 N Braddock Ave Ste 301 Pittsburgh PA US 15208

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
325870	1722703063	K192186	I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph	GWN	2019-11-29
325870	1484783625	K181025	I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System	GWN	2018-07-24
325870	1043869007	K171884	I-Portal Portable Assessment System - Nystagmograph (I-PAS)	GWN	2017-11-22
325870	1070067348	K143607	I-Portal NOTC, VNG and VOG	GWN	2015-07-08
325870	1990281953	K083603	I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL	GWN	2009-08-06

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GWN	5	2019-11-29