The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Red Dot 2515 Cardiac Sensor System.
| Device ID | K924487 |
| 510k Number | K924487 |
| Device Name: | RED DOT 2515 CARDIAC SENSOR SYSTEM |
| Classification | Stool, Anesthesia |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Julia L Wanamaker |
| Correspondent | Julia L Wanamaker 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | BRX |
| CFR Regulation Number | 868.6700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-03 |
| Decision Date | 1992-12-23 |