The following data is part of a premarket notification filed by Odam with the FDA for Maglife C.
| Device ID | K972535 |
| 510k Number | K972535 |
| Device Name: | MAGLIFE C |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ODAM 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 |
| Contact | STEVEN CLARKE |
| Correspondent | STEVEN CLARKE ODAM 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-08 |
| Decision Date | 1998-01-13 |