INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT

Hearing Aid, Air Conduction

SIEMENS HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Intelivenience Programmable Full Dynamic Range Compression Behind The Ear Hearing Instrument.

Pre-market Notification Details

Device IDK951896
510k NumberK951896
Device Name:INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
ClassificationHearing Aid, Air Conduction
Applicant SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. Piscataway,  NJ  08855
ContactGary W Roesel
CorrespondentGary W Roesel
SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. Piscataway,  NJ  08855
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-24
Decision Date1995-05-30

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