The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Gas-stat Monitoring System.
| Device ID | K831225 |
| 510k Number | K831225 |
| Device Name: | GAS-STAT MONITORING SYSTEM |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | CARDIOVASCULAR DEVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-15 |
| Decision Date | 1983-05-27 |