The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Ds Footankle 16ch Coils For 1.5t And 3.0t, Ds Hires Handwrist 16ch Coils For 1.5t And 3.0t, Ds Small Extremity 16ch Coils For 1.5t And 3.0t.
| Device ID | K213766 |
| 510k Number | K213766 |
| Device Name: | DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Invivo Corporation 3545 SW 47th Ave Gainesville, FL 32608 |
| Contact | Ann Lebar |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-01 |
| Decision Date | 2021-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838107939 | K213766 | 000 |
| 00884838118133 | K213766 | 000 |
| 00884838118164 | K213766 | 000 |
| 00884838118171 | K213766 | 000 |
| 00884838118188 | K213766 | 000 |
| 00884838118195 | K213766 | 000 |
| 00884838107861 | K213766 | 000 |
| 00884838107878 | K213766 | 000 |
| 00884838107908 | K213766 | 000 |
| 00884838107915 | K213766 | 000 |
| 00884838107922 | K213766 | 000 |
| 00884838118126 | K213766 | 000 |