The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.5t And 3.0t General Purpose Flex Coils.
| Device ID | K093842 |
| 510k Number | K093842 |
| Device Name: | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE Gainesville, FL 32608 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler INVIVO CORPORATION 3545 SW 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 | 2009-12-15 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067417 | K093842 | 000 |
| 00884838065581 | K093842 | 000 |
| 00884838065598 | K093842 | 000 |
| 00884838065604 | K093842 | 000 |
| 00884838066809 | K093842 | 000 |
| 00884838066885 | K093842 | 000 |
| 00884838066892 | K093842 | 000 |
| 00884838066908 | K093842 | 000 |
| 00884838066915 | K093842 | 000 |
| 00884838066922 | K093842 | 000 |
| 00884838067400 | K093842 | 000 |
| 00884838065574 | K093842 | 000 |