Sophono Bone Conduction Systems (S) Configuration And (M) Configuration

Hearing Aid, Bone Conduction

SOPHONO INC.

The following data is part of a premarket notification filed by Sophono Inc. with the FDA for Sophono Bone Conduction Systems (s) Configuration And (m) Configuration.

Pre-market Notification Details

Device IDK153391
510k NumberK153391
Device Name:Sophono Bone Conduction Systems (S) Configuration And (M) Configuration
ClassificationHearing Aid, Bone Conduction
Applicant SOPHONO INC. 5744 CENTRAL AVE #100 Boulder,  CO  80301
ContactRozanne Paciej
CorrespondentRozanne Paciej
SOPHONO INC. 5744 CENTRAL AVE #100 Boulder,  CO  80301
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-24
Decision Date2016-06-16
Summary:summary

NIH GUDID Devices

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