Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K234095
OtoNova/OtoNova Pro · Otodynamics · decided 2024-06-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| OtoNova Pro Fabric Carry Case | NPRO-CAS | OTODYNAMICS LIMITED | EWO GWJ | 05060396173738 |
| ABR Electrode Cable (SNAP) for OtoNova Pro | NPRO-SEC | OTODYNAMICS LIMITED | GWJ | 05060396172359 |
| OtoNova Pro Clinical | NPRO-CLN-D | OTODYNAMICS LIMITED | EWO | 05060396173714 |
| OtoNova Pro OAE+AABR instrument | OTONOVAPRO | OTODYNAMICS LIMITED | EWO GWJ | 05060396173011 |
| OtoNova Pro Clinical+AABR | NPRO-CLN-DA | OTODYNAMICS LIMITED | EWO GWJ | 05060396173721 |
| OtoNova Pro Screener DP+AABR | NPRO-SCR-DA | OTODYNAMICS LIMITED | EWO GWJ | 05060396173158 |
| ABR Electrode Cable (TAB) for OtoNova Pro | NPRO-TEC | OTODYNAMICS LIMITED | GWJ | 05060396172366 |
| OtoNova Pro Charger PCB Service Kit | ON2-CHG-KIT | OTODYNAMICS LIMITED | EWO GWJ | 05060396173059 |
| OtoNova Pro Infection Control Sleeve | NPRO-INF | OTODYNAMICS LIMITED | EWO GWJ | 05060396173783 |
| OtoNova Pro Screener TE+AABR | NPRO-SCR-TA | OTODYNAMICS LIMITED | EWO GWJ | 05060396173141 |
| OtoNova Pro Clinical+TE+AABR | NPRO-CLN-DTA | OTODYNAMICS LIMITED | EWO GWJ | 05060396173172 |
| Tablet Computer for OtoNova Pro | NOVA-TABLET | OTODYNAMICS LIMITED | EWO GWJ | 05060396171512 |
| OtoNova Pro Screener DP | NPRO-SCR-D | OTODYNAMICS LIMITED | EWO | 05060396173110 |
| OtoNova Pro User Manual | MANNPRO | OTODYNAMICS LIMITED | EWO GWJ | 05060396173479 |
| Crib/bassinet device holster for OtoNova | NOVA-CRIB | OTODYNAMICS LIMITED | EWO GWJ | 05060396171130 |
| OtoNova Pro Screener AABR | NPRO-SCR-A | OTODYNAMICS LIMITED | GWJ | 05060396173127 |
| OtoNova Pro Screener TE | NPRO-SCR-T | OTODYNAMICS LIMITED | EWO | 05060396173103 |
| OtoNova Pro Clinical+TE | NPRO-CLN-DT | OTODYNAMICS LIMITED | EWO | 05060396173486 |
| OtoNova Pro Main PCB Service Kit | ON2-MAIN | OTODYNAMICS LIMITED | EWO GWJ | 05060396173042 |
| OtoNova Pro Case Service Kit | ON2-CASE-KIT | OTODYNAMICS LIMITED | EWO GWJ | 05060396173080 |
| OtoNova Pro Screener DP+TE | NPRO-SCR-DT | OTODYNAMICS LIMITED | EWO | 05060396173134 |
| XPD Ear Probe | PR-XPD | OTODYNAMICS LIMITED | EWO GWJ | 05060396172243 |
| OtoNova Charger | NOVA-CHG | OTODYNAMICS LIMITED | EWO GWJ | 05060396171529 |
| OtoNova Battery Assembly Service Kit | ON-BATT-KIT | OTODYNAMICS LIMITED | EWO GWJ | 05060396172809 |
| OtoNova Pro Screener DP+TE+AABR | NPRO-SCR-DTA | OTODYNAMICS LIMITED | EWO GWJ | 05060396173165 |