The following data is part of a premarket notification filed by Invivo with the FDA for Hrk-63-16 Knee Array Coil, Hrk-127-16 Knee Array Coil.
| Device ID | K082987 |
| 510k Number | K082987 |
| Device Name: | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Andrew Adams |
| Correspondent | Andrew Adams 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 | 2008-10-07 |
| Decision Date | 2008-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086272 | K082987 | 000 |
| 00884838086104 | K082987 | 000 |
| 00884838066816 | K082987 | 000 |
| 00884838066755 | K082987 | 000 |
| 00884838065956 | K082987 | 000 |
| 00884838065949 | K082987 | 000 |