PHONAK SONO-FORTE 332X-AZ

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Sono-forte 332x-az.

Pre-market Notification Details

Device IDK946294
510k NumberK946294
Device Name:PHONAK SONO-FORTE 332X-AZ
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 Received1994-12-27
Decision Date1995-01-26

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