The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Cdi (tm) System 100 Monitoring System.
| Device ID | K902654 |
| 510k Number | K902654 |
| Device Name: | CDI (TM) SYSTEM 100 MONITORING SYSTEM |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, LTD. 2801 BARRANCA RD. Irvine, CA 92714 |
| Contact | John L Gehrich |
| Correspondent | John L Gehrich 3M HEALTH CARE, LTD. 2801 BARRANCA RD. Irvine, CA 92714 |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-11-05 |