CBZ — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling Class II
FDA product code CBZ covers "Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling", a Class II medical device regulated under 21 CFR 868.1170. Submissions are reviewed by the Anesthesiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CBZ
- Device Class
- Class II
- Regulation Number
- 868.1170
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K020967 | terumo cardiovascular systems | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | June 20, 2002 |
| K970906 | diametrics medical | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 | September 23, 1997 |
| K931112 | puritan bennett | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | June 1, 1993 |
| K920061 | abbott laboratories | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | March 30, 1992 |
| K912030 | 3m | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | October 30, 1991 |
| K912428 | puritan bennett | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT | August 9, 1991 |
| K884228 | cardiovascular devices | CDI(R) 2000 BLOOD GAS MONITOR | January 30, 1989 |
| K862114 | vascular technology incorporated | KHURI REGIONAL TISSUE PH MONITOR | June 25, 1986 |
| K803260 | biochem international | SENSOMAT MUSCLE/TISSUE PH | February 2, 1981 |
| K803014 | biochem international | SENSOMAT | December 22, 1980 |