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 IDK100193
510k NumberK100193
Device Name:OTOMAG BONE CONDUCTION HEARING SYSTEM
ClassificationHearing Aid, Bone Conduction
Applicant SOPHONO, INC 555 ZANG STREET SUITE 100 Lakewood,  CO  80228
ContactMary Armstrong
CorrespondentMary Armstrong
SOPHONO, INC 555 ZANG STREET SUITE 100 Lakewood,  CO  80228
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-22
Decision Date2010-05-18
Summary:summary

NIH GUDID Devices

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