The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.5t And 3.0t 16 Ch Ge Shoulder Coils.
| Device ID | K162001 |
| 510k Number | K162001 |
| Device Name: | 1.5T And 3.0T 16 CH GE Shoulder Coils |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE Gainesville, FL 32608 |
| Contact | Ken Revennaugh |
| Correspondent | Mark Job 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 | 2016-07-20 |
| Decision Date | 2016-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838081642 | K162001 | 000 |
| 00884838081635 | K162001 | 000 |
| 00884838081000 | K162001 | 000 |
| 00884838080997 | K162001 | 000 |