The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Khuri Myocardial Ph Monitoring System.
| Device ID | K020967 |
| 510k Number | K020967 |
| Device Name: | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM |
| Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. Tustin, CA 92780 |
| Contact | Steve Arick |
| Correspondent | Steve Arick TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. Tustin, CA 92780 |
| Product Code | CBZ |
| CFR Regulation Number | 868.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-06-20 |
| Summary: | summary |