The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162e,166m,168pp.
Device ID | K962170 |
510k Number | K962170 |
Device Name: | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP |
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 | 1996-06-05 |
Decision Date | 1996-07-25 |
Summary: | summary |