DYNA 231X

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Dyna 231x.

Pre-market Notification Details

Device IDK950758
510k NumberK950758
Device Name:DYNA 231X
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 EAST DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactWilliam Lesiecki
CorrespondentWilliam Lesiecki
PHONAK, INC. 850 EAST DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-17
Decision Date1995-03-21

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