Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K210197 |
Device Name |
NFC-600 Automated Portable Retinal Camera |
Applicant |
Crystalvue Medical Corporation |
No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., |
Taoyuan,
TW
33072
|
|
Applicant Contact |
Oliver Lin |
Correspondent |
Crystalvue Medical Corporation |
No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., |
Taoyuan,
TW
33072
|
|
Correspondent Contact |
Oliver Lin |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 01/25/2021 |
Decision Date | 04/13/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|