Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2519945

FEI Number

2519945

Entity Name

Spryson America Inc

City/State/Country

Blawnox, PA, US

Establishment Address

128 GAMMA DR., Blawnox, PA 15238, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spryson America Inc (Owner Number: 10090068)

Owner / Operator Contact Address

128 gamma drive, Pittsburgh, PA 15238, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192186

PMA Number

N/A

All Registered Proprietary Names

Neurolign Dx Falcon Spryson Dx 200 Neurolign Dx Spryson NOTC Spryson Dx Falcon Neurolign Dx Spryson NOTC Neurolign Dx Spryson Dx Falcon Neurolign Dx Falcon Spryson Dx 200 Neurolign Dx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWN	Nystagmograph	Neurology	Class 2	882.1460	2024-02-09
GWN	Nystagmograph	Neurology	Class 2	882.1460	2024-02-09
GWN	Nystagmograph	Neurology	Class 2	882.1460	2024-02-09
GWN	Nystagmograph	Neurology	Class 2	882.1460	2024-02-09

Official Correspondent

David Tsang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spryson America Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2519945. Last updated year: 2026. Please use registration number 2519945 when referencing this establishment in official correspondence.