K902654 is an FDA 510(k) clearance for the CDI (TM) SYSTEM 100 MONITORING SYSTEM. This device is classified as a Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DTY).
Submitted by 3M Health Care, Ltd. (Irvine, US). The FDA issued a Cleared decision on November 5, 1990, 143 days after receiving the submission on June 15, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4410.
| 510(k) Number | K902654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1990 |
| Decision Date | November 05, 1990 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTY — Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4410 |