PERSONAL PROGRAMMER 2000

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 Personal Programmer 2000.

Pre-market Notification Details

Device IDK952940
510k NumberK952940
Device Name:PERSONAL PROGRAMMER 2000
ClassificationHearing Aid, Air Conduction
Applicant SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway,  NJ  08855
ContactGary W Roesel
CorrespondentGary W Roesel
SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway,  NJ  08855
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-26
Decision Date1995-07-26

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