The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Red Dot 2560 & 2570 Monitoring Electrodes.
| Device ID | K970796 |
| 510k Number | K970796 |
| Device Name: | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Linda Johnsen |
| Correspondent | Linda Johnsen 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-04-09 |
| Summary: | summary |