Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K203500 |
Device Name |
RetCam Envision |
Applicant |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle |
Oakville,
CA
L6H 5S1
|
|
Applicant Contact |
Sanjay Mehta |
Correspondent |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle |
Oakville,
CA
L6H 5S1
|
|
Correspondent Contact |
Sanjay Mehta |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 11/30/2020 |
Decision Date | 04/13/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|