The following data is part of a premarket notification filed by Apollo Medical Optics, Ltd. with the FDA for Apollovue S100 Image System.
| Device ID | K201552 |
| 510k Number | K201552 |
| Device Name: | ApolloVue S100 Image System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Apollo Medical Optics, Ltd. 2F., No.43, Ln. 188, Ruiguang Rd., Neihu Dist. Taipei City, TW 114 |
| Contact | Chi-hua Wu |
| Correspondent | Feng-yu Lee Elite BioMedical Consulting, Inc. 29122 Rancho Viejo Rd. Suite 212 San Juan Capistrano, CA 92675 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2020-09-02 |