The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Intravascular Blood Gas System.
| Device ID | K843912 |
| 510k Number | K843912 |
| Device Name: | INTRAVASCULAR BLOOD GAS SYSTEM |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Contact | John L Gehrich |
| Correspondent | John L Gehrich CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-03 |
| Decision Date | 1985-01-10 |