The following data is part of a premarket notification filed by Invivo with the FDA for Hrb-127-32 High Resolution Brain Coil.
| Device ID | K082916 |
| 510k Number | K082916 |
| Device Name: | HRB-127-32 HIGH RESOLUTION BRAIN COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Jeff Wilkinson |
| Correspondent | Jeff Wilkinson INVIVO 3545 S.W. 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 | 2008-09-30 |
| Decision Date | 2008-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086395 | K082916 | 000 |