The following data is part of a premarket notification filed by Magna Lab, Inc. with the FDA for Cardiac View, Model 2001.
| Device ID | K010802 |
| 510k Number | K010802 |
| Device Name: | CARDIAC VIEW, MODEL 2001 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MAGNA LAB, INC. 150 CALIFORNIA ST. Newton, MA 02458 |
| Contact | Lynn Carter |
| Correspondent | Lynn Carter MAGNA LAB, INC. 150 CALIFORNIA ST. Newton, MA 02458 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-16 |
| Decision Date | 2001-06-08 |