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OtoNova Pro Fabric Carry Case

OTODYNAMICS LIMITED · Model NPRO-CAS · UDI-DI 05060396173738

EWOGWJ
1
510(k) clearances
65
Adverse events
5
Recalls
65
Facilities

Description

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

Recalls

DateFirmReason
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16Cardinal Health, IncGSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.