Device Classification Name |
Ophthalmoscope, Laser, Scanning
|
510(k) Number |
K192113 |
Device Name |
DRSplus |
Applicant |
CenterVue SpA |
Via S. Marco 9H |
Padova,
IT
35129
|
|
Applicant Contact |
Roberto Gabriotti |
Correspondent |
CenterVue SpA |
Via S. Marco 9H |
Padova,
IT
35129
|
|
Correspondent Contact |
Roberto Gabriotti |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 08/05/2019 |
Decision Date | 11/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|