PHONAK MICROLINK, PERSONAL FM RECEIVER

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Microlink, Personal Fm Receiver.

Pre-market Notification Details

Device IDK964035
510k NumberK964035
Device Name:PHONAK MICROLINK, PERSONAL FM RECEIVER
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactHelmut Ermann
CorrespondentHelmut Ermann
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 Received1996-10-08
Decision Date1996-12-04
Summary:summary

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