The following data is part of a premarket notification filed by St. Jude Medical (now Abbott Medical) with the FDA for Ilumien Optis, Optis Integrated, Optis Mobile.
| Device ID | K183320 |
| 510k Number | K183320 |
| Device Name: | Ilumien Optis, Optis Integrated, Optis Mobile |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | St. Jude Medical (now Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Steve Vitale |
| Correspondent | Steve Vitale St. Jude Medical (now Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067030108 | K183320 | 000 |