otodynamics.comOtoNova/OtoNova Pro
Otodynamics
OTODYNAMICS, LTD.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8021990 | 2939 | OTODYNAMICS, LTD. | 1 | N | 2026-01-01 | 30-38 BEACONSFIELD RD. HATFIELD, HERTS Hertfordshire GB AL10 8BB |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060396171130 | Crib/bassinet device holster for OtoNova - NOVA-CRIB | 1-800-659-7776 | info@otodynamics.com |
| 05060396171512 | Tablet Computer for OtoNova Pro - Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement. | 1-800-659-7776 | info@otodynamics.com |
| 05060396171529 | OtoNova Charger - Medical Power Supply Unit for OtoNova Wireless Charging Pad | 1-800-659-7776 | info@otodynamics.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 73867 | 1546884870 | K240430 | Otoport Pro | EWO | 2024-03-15 |
| 73867 | 1458865200 | K234095 | OtoNova/OtoNova Pro | EWO | 2024-06-21 |
| 73867 | 2043132663 | K143395 | Otoport 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 Kit | EWO | 2015-02-23 |
| 73867 | 2008938573 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EWO | 3 | 2024-06-21 |
PMN
Otoport Pro
Otodynamics, Ltd.
Otoport 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 Kit
OTODYNAMICS, LTD.
OTODYNAMICS OTOPORT
OTODYNAMICS, LTD.
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
OTODYNAMICS, LTD.
ILO292 DP ECHOPORT PLUS OAE SYSTEM
OTODYNAMICS, LTD.
ILO292 DP ECHOPORT PLUS OAE SYSTEM
OTODYNAMICS, LTD.
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
OTODYNAMICS, LTD.
GUDID
Crib/bassinet device holster for OtoNova - NOVA-CRIB
2024-08-20
Tablet Computer for OtoNova Pro - Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
2024-08-20
OtoNova Charger - Medical Power Supply Unit for OtoNova Wireless Charging Pad
2024-08-20
OtoNova Wireless Charging Pad - Wireless Charging Pad for OtoNova/OtoNova Pro. WPC (Qi) specification v1.2
2024-08-20
XPD Ear Probe - Next generation 'X-series' general purpose ear probe for TEOAE and DPOAE hearing screening/analysis, auditory stimulus for AABR; 1.2 metre cable, 14-pin push/pull plug. For use with Otoport Pro and OtoNova Pro OAE and OAE+AABR instruments.
2024-08-20
ABR Electrode Cable (SNAP) for OtoNova Pro - ABR electrode cable for use with 4mm SNAP electrodes, length 44"/1.1M, Red/Black/White color coding, straight 4-pin yellow plug, for use with OtoNova Pro
2024-08-20
ABR Electrode Cable (TAB) for OtoNova Pro - ABR electrode cable for use with TAB electrodes, length 44"/1.1M, Red/Black/White color coding, straight yellow 4-pin plug, for use with OtoNova Pro
2024-08-20
OtoNova Battery Assembly Service Kit - OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)
2024-08-20
OtoNova Pro OAE+AABR instrument - OtoNova Pro OAE & ABR device for wireless use with tablet, smartphone, or PC (instrument only - no system items)
2024-08-20
OtoNova Pro Main PCB Service Kit - Main PCB service kit for OtoNova Pro(for authorised dealers/repair centers only)
2024-08-20
OtoNova Pro Charger PCB Service Kit - Charger PCB service kit for OtoNova Pro (for authorised dealers/repair centers only)
2024-08-20
OtoNova Pro Case Service Kit - Case (enclosure) service kit for OtoNova Pro. Includes fascias, LED Touch circuit, switch membrane & NFC antenna (for authorised dealers/repair centers only)
2024-08-20
OtoNova Pro Screener TE - OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app
2024-08-20
OtoNova Pro Screener DP - OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
2024-08-20
OtoNova Pro Screener AABR - OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
2024-08-20
OtoNova Pro Screener DP+TE - OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
2024-08-20
OtoNova Pro Screener TE+AABR - OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
2024-08-20
OtoNova Pro Screener DP+AABR - OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
2024-08-20
OtoNova 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 app
2024-08-20
OtoNova 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 app
2024-08-20
OtoNova Pro User Manual - Instructions For Use (User Manual) for OtoNova Pro, English
2024-08-20
OtoNova Pro Clinical+TE - OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
2024-08-20
OtoNova Pro Clinical - OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
2024-08-20
OtoNova Pro Clinical+AABR - OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
2024-08-20
OtoNova Pro Fabric Carry Case - Lightweight carry case for the OtoNova Pro kit, with sections for OtoNova Pro, charger, wireless charging pad, probes, probe tips box and test cavity. Handy compartments inside and outside for documentation and pens. Detachable shoulder strap. Dimensions: 325mm x 265mm x 100mm
2024-08-20
OtoNova Pro Infection Control Sleeve - Transparent, easy-clean cover for optional use with OtoNova Pro. Available in packs of 10.
2024-08-20
Otoport Pro Case service kit - Case (enclosure) service kit for Otoport Pro (for authorised dealers/repair centres only)
2024-07-18
ABR Electrode Cable V2 (SNAP) for Otoport V2/Pro - ABR electrodes cable for use with 4mm SNAP electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin plug, for use with Otoport Pro
2024-07-17
ABR Electrode Cable V2 (TAB) for Otoport V2/Pro - ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin plug, for use with Otoport Pro
2024-07-17
ABR Electrode Cable V2 (NHSP) for Otoport V2/Pro - ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Black/Green/White colour coding for NHSP, right-angle yellow 4-pin plug, for use with Otoport Pro
2024-07-17
Otoport Pro OAE+AABR instrument - Handheld, portable, Otoacoustic Emission (OAE) & Auditory Brainstem Response (AABR) analyser, for hearing screening applications. Otoport Pro device only. Part code used for reference/regulatory purposes. Device sold only with system, unless replacement.
2024-07-17
Otoport Pro Screener DP - Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and DPOAE Screener licence
2024-07-17
Otoport Pro Screener TE - Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and TEOAE Screener licence
2024-07-17
Otoport Pro Screener DP+TE - Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+TEOAE Screener licence
2024-07-17
Otoport Pro Screener AABR - Handheld, portable, Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and ABR Screener licence
2024-07-17
Otoport Pro Screener DP+AABR - Handheld, portable, Otoacoustic Emission [OAE] and Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+AABR Screener licence
2024-07-17
Otoport Pro Screener TE+AABR - Handheld, portable, Otoacoustic Emission [OAE] and Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and TEOAE+AABR Screener licence
2024-07-17
Otoport Pro Screener DP+TE+AABR - Handheld, portable, Otoacoustic Emission [OAE] and Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+TEOAE+AABR Screener licence
2024-07-17
Otoport Pro Clinical - Handheld, portable, Otoacoustic Emission [OAE] analyser for Clinical OAE hearing test applications. Includes Otoport Pro instrument, ear probe, system items, and DPOAE Clinical licence
2024-07-17
Otoport Pro Clinical+TE - Handheld, portable, Otoacoustic Emission [OAE] analyser for Clinical OAE hearing test applications. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+TEOAE Clinical licence
2024-07-17