FDA-Device2025-12-24Class II
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
PATH
Hazard
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 thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
Sold states
Domestic: WI. International: Ireland.
Manufactured in
Landsberger Str. 65, Germering, Germany
Products
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2026Don't want to check this manually?
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