The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Cdi Blood Parameter Monitoring System 500.
| Device ID | K972962 |
| 510k Number | K972962 |
| Device Name: | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | 3M COMPANY 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Anne Buteyn |
| Correspondent | Anne Buteyn 3M COMPANY 1311 VALENCIA AVE. Tustin, CA 92680 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-11-06 |
| Summary: | summary |