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ABR Electrode Cable (TAB) for OtoNova Pro
OTODYNAMICS LIMITED · Model NPRO-TEC · UDI-DI 05060396172366
1
510(k) clearances
119
Adverse events
4
Recalls
58
Facilities
Description
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
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap |
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