Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K182263 |
Device Name |
RetCam 3 ; RetCam Shuttle ; RetCam Portable |
Applicant |
Natus Medical Incorporated |
1183 Quarry Lane, Suite A |
Pleasanton,
CA
94566
|
|
Applicant Contact |
Brian R. Ackley |
Correspondent |
Natus Medical Incorporated |
1183 Quarry Lane, Suite A |
Pleasanton,
CA
94566
|
|
Correspondent Contact |
Brian R. Ackley |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/21/2018 |
Decision Date | 09/07/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|