Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K201552 |
Device Name |
ApolloVue S100 Image System |
Applicant |
Apollo Medical Optics, Ltd. |
2F., No.43, Ln. 188, Ruiguang Rd., Neihu Dist. |
Taipei City,
TW
114
|
|
Applicant Contact |
Chi-Hua Wu |
Correspondent |
Elite BioMedical Consulting, Inc. |
29122 Rancho Viejo Rd. Suite 212 |
San Juan Capistrano,
CA
92675
|
|
Correspondent Contact |
Feng-Yu Lee |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 06/10/2020 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|