Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K921443 |
Device Name |
TIP & MEMBRANE ASSEMBLY |
Applicant |
BIO-RAD |
635 WEST COLORADO ST. |
GLENDALE,
CA
91204
|
|
Applicant Contact |
RICHARD W TEASDALE |
Correspondent |
BIO-RAD |
635 WEST COLORADO ST. |
GLENDALE,
CA
91204
|
|
Correspondent Contact |
RICHARD W TEASDALE |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 02/25/1992 |
Decision Date | 06/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|