The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.5t And 3t 8-channel Medium General Purpose Flex Coil.
| Device ID | K111673 |
| 510k Number | K111673 |
| Device Name: | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler INVIVO CORPORATION 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2011-12-23 |
| Summary: | summary |