The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Cdi(r) 2000 Blood Gas Monitor.
| Device ID | K884228 |
| 510k Number | K884228 |
| Device Name: | CDI(R) 2000 BLOOD GAS MONITOR |
| Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Applicant | CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Contact | Steven Arick |
| Correspondent | Steven Arick CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Product Code | CBZ |
| CFR Regulation Number | 868.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-07 |
| Decision Date | 1989-01-30 |