The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Personal Programmer 2000.
Device ID | K952940 |
510k Number | K952940 |
Device Name: | PERSONAL PROGRAMMER 2000 |
Classification | Hearing Aid, Air Conduction |
Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
Contact | Gary W Roesel |
Correspondent | Gary W Roesel SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-26 |
Decision Date | 1995-07-26 |