The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Gast Stat Monitoring System.
| Device ID | K840749 |
| 510k Number | K840749 |
| Device Name: | GAST STAT MONITORING SYSTEM |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | CARDIOVASCULAR DEVICES, INC. CA |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-17 |