PHONAK MICROVOX RESONAL FM SYSTEM

Hearing Aid, Group And Auditory Trainer

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Microvox Resonal Fm System.

Pre-market Notification Details

Device IDK941768
510k NumberK941768
Device Name:PHONAK MICROVOX RESONAL FM SYSTEM
ClassificationHearing Aid, Group And Auditory Trainer
Applicant PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
ContactBill Lesiecki
CorrespondentBill Lesiecki
PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
Product CodeEPF  
CFR Regulation Number874.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-11
Decision Date1994-06-24

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