Device Classification Name |
System, Image Management, Ophthalmic
|
510(k) Number |
K200954 |
Device Name |
Glaucoma Module |
Applicant |
Topcon Healthcare Solutions, Inc. |
111 Bauer Drive |
Oakland,
NJ
07436
|
|
Applicant Contact |
Ramya Sundaram |
Correspondent |
O'Connell Regulatory Consultants, Inc. |
44 Oak Street |
Stoneham,
MA
02180
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/09/2020 |
Decision Date | 08/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|