FDA-Device2023-12-06Class II

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

PATH
Hazard

Affected lots of product may experience technical distortions to a greater extent than expected.

Sold states
US States: FL, MO, OH, WI
Affected count
23 units
Manufactured in
Landsberger Str. 65, Germering, Germany
Products
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2024

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