Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K182199 |
Device Name |
NFC-700 non-mydriatic auto fundus 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 | 08/14/2018 |
Decision Date | 01/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|