The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Real Intelligence Cori (cori).
| Device ID | K212537 |
| 510k Number | K212537 |
| Device Name: | REAL INTELLIGENCE CORI (CORI) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441 |
| Contact | Sarah Plittman |
| Correspondent | Sarah Plittman Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-12 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556806609 | K212537 | 000 |
| 00885556806548 | K212537 | 000 |