PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Lexa 231x Ite Series Hearing Sinstrument.

Pre-market Notification Details

Device IDK932175
510k NumberK932175
Device Name:PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
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 Received1993-05-05
Decision Date1993-07-08

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