PHONAK PICONET 232X-AZ HEARING INSTRUMENT

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Piconet 232x-az Hearing Instrument.

Pre-market Notification Details

Device IDK945439
510k NumberK945439
Device Name:PHONAK PICONET 232X-AZ HEARING INSTRUMENT
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactWilliam Lesiecki
CorrespondentWilliam Lesiecki
PHONAK, INC. 850 E. 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 Received1994-10-28
Decision Date1995-08-23

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