Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K974501 |
Device Name |
DIGITAL TINNITUS MASKING SYSTEM |
Applicant |
PETROFF AUDIO TECHNOLOGIES |
6520 PLATT AVE., #813 |
WEST HILLS,
CA
91307
|
|
Applicant Contact |
MICHAEL L PETROFF |
Correspondent |
PETROFF AUDIO TECHNOLOGIES |
6520 PLATT AVE., #813 |
WEST HILLS,
CA
91307
|
|
Correspondent Contact |
MICHAEL L PETROFF |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 11/28/1997 |
Decision Date | 01/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|