The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Modified Gas-stat(tm) Monitoring System.
| Device ID | K864703 |
| 510k Number | K864703 |
| Device Name: | MODIFIED GAS-STAT(TM) MONITORING SYSTEM |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Contact | Gehrich, Phd |
| Correspondent | Gehrich, Phd CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1987-02-19 |