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ETYMOTIC RESEARCH, INC. · Model ER3C-300 · UDI-DI 00846430005488

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510(k) clearances

Adverse events

Recalls

Facilities

Description

ER3C-300 System consists of the following items: ER3C-300 Audiometric Insert Earphones, ER3C-84 7' cable with dual-mono 6.33 mm (1/4") plugs or ER3-19 Cable Shielded 300 Ohm 16' (ABR) or ER3-31 Shielded (ABR) Cable, or ER3-32 Shielded (ABR) Cable, ER3C-14A foam eartips (regular, 13 mm), ER3C-14B foam eartips (small, 10 mm), ER3C-14C foam eartips (large, 18 mm)

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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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.