K900860 is an FDA 510(k) clearance for the PERFUSION MONITOR. This device is classified as a Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DTY).
Submitted by Cardio Metrics, Inc. (Sugar Land, US). The FDA issued a Cleared decision on August 14, 1990, 172 days after receiving the submission on February 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4410.
| 510(k) Number | K900860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1990 |
| Decision Date | August 14, 1990 |
| Days to Decision | 172 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 |