The following data is part of a premarket notification filed by Mayo Clinic with the FDA for Mayo Clinic Bc-10 3.0t.
| Device ID | K040122 |
| 510k Number | K040122 |
| Device Name: | MAYO CLINIC BC-10 3.0T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Mayo Clinic 200 FIRST ST. SW Rochester, MN 55905 |
| Contact | Jade Sadosty |
| Correspondent | Jade Sadosty Mayo Clinic 200 FIRST ST. SW Rochester, MN 55905 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851607003024 | K040122 | 000 |