The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Ctl-63 And Ctl-128 Spine Array Coils.
| Device ID | K062767 |
| 510k Number | K062767 |
| Device Name: | CTL-63 AND CTL-128 SPINE ARRAY COILS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee, WI 53072 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2006-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838066700 | K062767 | 000 |
| 00884838066694 | K062767 | 000 |