LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS

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 Lifesound Multiple Situation, Single Channel Programmable Instruments.

Pre-market Notification Details

Device IDK944174
510k NumberK944174
Device Name:LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
ClassificationHearing Aid, Air Conduction
Applicant SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. Piscataway,  NJ  08855
ContactGary Roesel
CorrespondentGary 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 Received1994-08-26
Decision Date1994-12-27

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