OTOMAG BONE CONDUCTION HEARING SYSTEM

Hearing Aid, Bone Conduction

SOPHONO, INC

The following data is part of a premarket notification filed by Sophono, Inc with the FDA for Otomag Bone Conduction Hearing System.

Pre-market Notification Details

Device IDK123962
510k NumberK123962
Device Name:OTOMAG BONE CONDUCTION HEARING SYSTEM
ClassificationHearing Aid, Bone Conduction
Applicant SOPHONO, INC 5744 CENTRAL AVENUE #100 Boulder,  CO  80301
ContactKrista B Traynor
CorrespondentKrista B Traynor
SOPHONO, INC 5744 CENTRAL AVENUE #100 Boulder,  CO  80301
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169645318 K123962 000

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