Device Classification Name |
tomography, optical coherence
|
510(k) Number |
K121622 |
Device Name |
NIDEK RS-3000 |
Applicant |
NIDEK CO., LTD. |
1667 RIDGEWOOD RD |
WADSWORTH,
OH
44281
|
|
Applicant Contact |
LENA SATTLER |
Correspondent |
NIDEK CO., LTD. |
1667 RIDGEWOOD RD |
WADSWORTH,
OH
44281
|
|
Correspondent Contact |
LENA SATTLER |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 03/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|