K840749 is an FDA 510(k) clearance for the GAST STAT 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. (Anaheim, US). The FDA issued a Cleared decision on April 17, 1984, 54 days after receiving the submission on February 23, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4410.
| 510(k) Number | K840749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1984 |
| Decision Date | April 17, 1984 |
| Days to Decision | 54 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 |