The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Red Dot Resting Ekg Electrode, Catalog 2360.
| Device ID | K974445 |
| 510k Number | K974445 |
| Device Name: | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 |
| Classification | Electrode, Electrocardiograph |
| Applicant | 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -1000 |
| Contact | Linda Johnsen |
| Correspondent | Linda Johnsen 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -1000 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-07-26 |
| Summary: | summary |