Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K992606 |
Device Name |
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 |
Applicant |
CANON U.S.A., INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042 -1198
|
|
Applicant Contact |
KEN SHADOFF |
Correspondent |
CANON U.S.A., INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042 -1198
|
|
Correspondent Contact |
KEN SHADOFF |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 08/03/1999 |
Decision Date | 06/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|