The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 7000 Monitor Module.
| Device ID | K801097 |
| 510k Number | K801097 |
| Device Name: | SARNS 7000 MONITOR MODULE |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-09 |
| Decision Date | 1980-05-20 |