SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE

Hearing Aid, Air Conduction

RESOUND CORP.

The following data is part of a premarket notification filed by Resound Corp. with the FDA for Sonar Cic Completely In-the-canal Hearing Device.

Pre-market Notification Details

Device IDK952228
510k NumberK952228
Device Name:SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
ClassificationHearing Aid, Air Conduction
Applicant RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City,  CA  94063
ContactKrista M Buckles
CorrespondentKrista M Buckles
RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City,  CA  94063
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-11
Decision Date1995-06-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.