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.
Device ID | K944174 |
510k Number | K944174 |
Device Name: | LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS |
Classification | Hearing Aid, Air Conduction |
Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. Piscataway, NJ 08855 |
Contact | Gary Roesel |
Correspondent | Gary Roesel SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. 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 | 1994-08-26 |
Decision Date | 1994-12-27 |