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Otodynamics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80219902939OTODYNAMICS, LTD.1N2026-01-0130-38 BEACONSFIELD RD. HATFIELD, HERTS Hertfordshire GB AL10 8BB

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060396173165OtoNova Pro Screener DP+TE+AABR - OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app1-800-659-7776info@otodynamics.com
05060396173172OtoNova Pro Clinical+TE+AABR - OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app1-800-659-7776info@otodynamics.com
05060396173479OtoNova Pro User Manual - Instructions For Use (User Manual) for OtoNova Pro, English1-800-659-7776info@otodynamics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
738671546884870K240430Otoport ProEWO2024-03-15
738671458865200K234095OtoNova/OtoNova ProEWO2024-06-21
738672043132663K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade KitEWO2015-02-23
738672008938573

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EWO32024-06-21

PMN#

GUDID#

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