The following data is part of a premarket notification filed by Invivo with the FDA for Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 And Cac-127-16.
| Device ID | K061952 |
| 510k Number | K061952 |
| Device Name: | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert 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 | 2006-07-10 |
| Decision Date | 2006-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080843 | K061952 | 000 |
| 00884838066113 | K061952 | 000 |
| 00884838066120 | K061952 | 000 |
| 00884838066137 | K061952 | 000 |
| 00884838066144 | K061952 | 000 |
| 00884838066151 | K061952 | 000 |
| 00884838066489 | K061952 | 000 |
| 00884838066557 | K061952 | 000 |
| 00884838066564 | K061952 | 000 |
| 00884838066571 | K061952 | 000 |
| 00884838066717 | K061952 | 000 |
| 00884838066724 | K061952 | 000 |
| 00884838067066 | K061952 | 000 |
| 00884838067073 | K061952 | 000 |
| 00884838067226 | K061952 | 000 |
| 00884838067233 | K061952 | 000 |
| 00884838067264 | K061952 | 000 |
| 00884838066106 | K061952 | 000 |