Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K011199 |
Device Name |
PROVIEW EYE PRESSURE MONITOR |
Applicant |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Applicant Contact |
DOUGLAS J FORTUNATO |
Correspondent |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Correspondent Contact |
DOUGLAS J FORTUNATO |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 04/19/2001 |
Decision Date | 07/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|