PHONAK PICONET 231-X

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 231-x.

Pre-market Notification Details

Device IDK930145
510k NumberK930145
Device Name:PHONAK PICONET 231-X
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactBill Lesiecki
CorrespondentBill 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 Received1993-01-12
Decision Date1993-02-01

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