The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Real Intelligence Cori.
| Device ID | K220958 |
| 510k Number | K220958 |
| Device Name: | Real Intelligence Cori |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441 |
| Contact | Unnati Bhuptani |
| Correspondent | Unnati Bhuptani Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441 |
| Product Code | OLO |
| Subsequent Product Code | HSX |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-07-27 |