The following data is part of a premarket notification filed by Medimaging Integrated Solutions, Inc. (miis) with the FDA for Digital Eye-fundus Camera.
| Device ID | K120982 |
| 510k Number | K120982 |
| Device Name: | DIGITAL EYE-FUNDUS CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) 1F, NO. 7, R&D RD II HSUNCHU SCIENCE PARK Hsinchu, CN 30076 |
| Contact | Chih-lu Hsu |
| Correspondent | Chih-lu Hsu MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) 1F, NO. 7, R&D RD II HSUNCHU SCIENCE PARK Hsinchu, CN 30076 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6333974203P0 | K120982 | 000 |
| M6333974370 | K120982 | 000 |
| M6333974390 | K120982 | 000 |
| M6333974430 | K120982 | 000 |
| M6333974050 | K120982 | 000 |
| M6333974080 | K120982 | 000 |
| M6333974200 | K120982 | 000 |
| M63339742020 | K120982 | 000 |
| M6333974202P0 | K120982 | 000 |
| M63339742030 | K120982 | 000 |
| M63339743610 | K120982 | 000 |