Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021990

FEI Number

2939

Entity Name

OTODYNAMICS, LTD.

City/State/Country

HATFIELD, HERTS Hertfordshire, GB

Establishment Address

30-38 BEACONSFIELD RD., HATFIELD, HERTS Hertfordshire AL10 8BB, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OTODYNAMICS, LTD. (Owner Number: 8021990)

Owner / Operator Contact Address

32-34 BEACONSFIELD RD., --, HATFIELD, HERTS, GB-NOTA AL10 8BB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K234095

PMA Number

N/A

All Registered Proprietary Names

ILO288 Echoport USB ILO292 Echoport USB Otocheck Otoport Otoport/Otocheck Otoport Pro OtoNova/OtoNova Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2002-01-14
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2016-08-08
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-07-02
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2024-07-02
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2024-07-02
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

OTODYNAMICS, LTD.

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
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021990. Last updated year: 2026. Please use registration number 8021990 when referencing this establishment in official correspondence.