Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022229

FEI Number

3715

Entity Name

ETYMONIC DESIGN, INC.

City/State/Country

DORCHESTER Ontario, CA

Establishment Address

20 LUDWIG ST., DORCHESTER Ontario NOL 1G4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ETYMONIC DESIGN, INC. (Owner Number: 8022229)

Owner / Operator Contact Address

20 Ludwig St., --, Dorchester, CA-ON NOL 1G4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012306

PMA Number

N/A

All Registered Proprietary Names

audioscan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2007-10-31

Official Correspondent

Keith Harasyn

US Agent Details

David Smriga Business: David J Smriga Consulting (A Division of AuDNet, Inc.) Email: dvsm@audioscan.com Phone: (952) 9539533

Related Public Records

Same Entity

ETYMONIC DESIGN, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022229. Last updated year: 2026. Please use registration number 8022229 when referencing this establishment in official correspondence.