Device Classification Name |
Audiometer
|
510(k) Number |
K003364 |
Device Name |
VIVO 200 DPS VIVOSCAN |
Applicant |
VIVOSONIC, INC. |
1151 HOPE ST. |
STAMFORD,
CT
06907
|
|
Applicant Contact |
RICHARD KEEN |
Correspondent |
VIVOSONIC, INC. |
1151 HOPE ST. |
STAMFORD,
CT
06907
|
|
Correspondent Contact |
RICHARD KEEN |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 10/27/2000 |
Decision Date | 07/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|