The following data is part of a premarket notification filed by 3m Company with the FDA for Sarns 9000 Perfusion System W/alert Only Level.
| Device ID | K900815 |
| 510k Number | K900815 |
| Device Name: | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | James Balun |
| Correspondent | James Balun 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-05-09 |