Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K021937 |
Device Name |
TGDC-01 PRA |
Applicant |
TRUEVISION INSTRUMENTS |
4220 CESAR CHAVEZ #536 |
SAN FRANCISCO,
CA
94131
|
|
Applicant Contact |
RALF THOMAIER |
Correspondent |
TRUEVISION INSTRUMENTS |
4220 CESAR CHAVEZ #536 |
SAN FRANCISCO,
CA
94131
|
|
Correspondent Contact |
RALF THOMAIER |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 06/12/2002 |
Decision Date | 10/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|