CUSTOM IN-THE-EAR HEARING AID

Hearing Aid, Air Conduction

FINETONE HEARING INSTRUMENTS

The following data is part of a premarket notification filed by Finetone Hearing Instruments with the FDA for Custom In-the-ear Hearing Aid.

Pre-market Notification Details

Device IDK830960
510k NumberK830960
Device Name:CUSTOM IN-THE-EAR HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant FINETONE HEARING INSTRUMENTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-25
Decision Date1983-06-30

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