The following data is part of a premarket notification filed by Medimaging Integrated Solution Inc. (miis) with the FDA for Digital Eye Anterior Camera.
| Device ID | K170470 |
| 510k Number | K170470 |
| Device Name: | Digital Eye Anterior Camera |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, TW 30076 |
| Contact | Yi-ying Chen |
| Correspondent | Yi-ying Chen Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, TW 30076 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6333974333P0 | K170470 | 000 |
| M63339743320 | K170470 | 000 |
| M6333974330 | K170470 | 000 |
| M6333974290 | K170470 | 000 |