The following data is part of a premarket notification filed by Medimaging Integrated Solution Inc. (miis) with the FDA for Miis Horus Eye Anterior Camera.
| Device ID | K193188 |
| 510k Number | K193188 |
| Device Name: | MiiS Horus Eye Anterior Camera |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Medimaging Integrated Solution Inc. (MiiS) 3F.,No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, CN 30077 |
| Contact | Yi-ying Chen |
| Correspondent | Yi-ying Chen Medimaging Integrated Solution Inc. (MiiS) 3F.,No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, CN 30077 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-01-14 |