The following data is part of a premarket notification filed by Trice Medical with the FDA for Mi-eye 2, Mi-eye 2 Monitor.
| Device ID | K162475 |
| 510k Number | K162475 |
| Device Name: | Mi-eye 2, Mi-eye 2 Monitor |
| Classification | Arthroscope |
| Applicant | Trice Medical 1000 Continental Dr. Suite 240 King Of Prussia, PA 19406 |
| Contact | Tiffini Diage |
| Correspondent | Tiffini Diage Trice Medical 1000 Continental Dr. Suite 240 King Of Prussia, PA 19406 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861578000362 | K162475 | 000 |
| 00861578000355 | K162475 | 000 |
| 00861578000348 | K162475 | 000 |
| 00861578000331 | K162475 | 000 |
| 00857356008064 | K162475 | 000 |
| 00857356008118 | K162475 | 000 |
| 00857356008026 | K162475 | 000 |