The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Sense Msk S 8ch 1.5t.
| Device ID | K120122 |
| 510k Number | K120122 |
| Device Name: | SENSE MSK S 8CH 1.5T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838065994 | K120122 | 000 |