AUDALLION II HEARING SYSTEM

Hearing Aid, Air Conduction

RESOUND CORP.

The following data is part of a premarket notification filed by Resound Corp. with the FDA for Audallion Ii Hearing System.

Pre-market Notification Details

Device IDK970215
510k NumberK970215
Device Name:AUDALLION II HEARING SYSTEM
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 Received1997-01-21
Decision Date1997-03-31
Summary:summary

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