Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K962170 |
Device Name |
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP |
Applicant |
SIEMENS HEARING INSTRUMENTS, INC. |
10 CONSTITUTION AVE. |
P.O. BOX 1397 |
PISCATAWAY,
NJ
08855
|
|
Applicant Contact |
GARY W ROESEL |
Correspondent |
SIEMENS HEARING INSTRUMENTS, INC. |
10 CONSTITUTION AVE. |
P.O. BOX 1397 |
PISCATAWAY,
NJ
08855
|
|
Correspondent Contact |
GARY W ROESEL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/05/1996 |
Decision Date | 07/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|