Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K970887 |
Device Name |
BLOOD FLOW ANALYZER |
Applicant |
PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
RICHARD DIRKSON |
Correspondent |
PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
RICHARD DIRKSON |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 03/11/1997 |
Decision Date | 06/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|