Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K092883 |
Device Name |
LED LAMP OR OTHER |
Applicant |
INTRAVISTA MEDICAL SYSTEMS INC |
1567 SAMEDRA ST |
SUNNYVALE,
CA
94087
|
|
Applicant Contact |
WEI SU |
Correspondent |
INTRAVISTA MEDICAL SYSTEMS INC |
1567 SAMEDRA ST |
SUNNYVALE,
CA
94087
|
|
Correspondent Contact |
WEI SU |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 09/18/2009 |
Decision Date | 12/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|