The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Universal Level Sensor.
| Device ID | K831879 |
| 510k Number | K831879 |
| Device Name: | UNIVERSAL LEVEL SENSOR |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-13 |
| Decision Date | 1983-07-26 |