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 |