The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Cdi 100 Extracorporeal Hematocrit/oxygen Saturatio.
| Device ID | K931968 |
| 510k Number | K931968 |
| Device Name: | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, LTD. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Steven Arick |
| Correspondent | Steven Arick 3M HEALTH CARE, LTD. 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 | 1993-04-21 |
| Decision Date | 1993-11-10 |