K864703 is an FDA 510(k) clearance for the MODIFIED GAS-STAT(TM) MONITORING SYSTEM. This device is classified as a Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DTY).
Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 1987, 79 days after receiving the submission on December 2, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4410.
| 510(k) Number | K864703 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1986 |
| Decision Date | February 19, 1987 |
| Days to Decision | 79 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 |