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ETYMOTIC RESEARCH, INC. · Model ER3C-50 System · UDI-DI 00846430005051
1
510(k) clearances
65
Adverse events
5
Recalls
65
Facilities
Description
ER3C-50 Insert Earphone (pair) ER3-21 audiometric tubing, ER003452AR foam ear tips (13mm) ER003453AR foam ear tips (10mm) ER003454AR foam ear tips (18mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2008-09-16 | Cardinal Health, Inc | GSI 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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Get your free API keyRead the docsData 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.