FDA.reportPublic FDA data

OTODYNAMICS, LTD.

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
05060396171130Crib/bassinet device holster for OtoNova - NOVA-CRIB1-800-659-7776info@otodynamics.com
05060396171512Tablet Computer for OtoNova Pro - Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.1-800-659-7776info@otodynamics.com
05060396171529OtoNova Charger - Medical Power Supply Unit for OtoNova Wireless Charging Pad1-800-659-7776info@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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