The following data is part of a premarket notification filed by 3m Company with the FDA for Red Dot Cardiac Sensor System.
| Device ID | K896155 |
| 510k Number | K896155 |
| Device Name: | RED DOT CARDIAC SENSOR SYSTEM |
| Classification | Electrode, Electrocardiograph |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | Julia L Wannamaker |
| Correspondent | Julia L Wannamaker 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1989-12-13 |