Product code CBZ— Anesthesiology
CDI(R) 2000 BLOOD GAS MONITOR
- Classification name
- Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device class
- Class 2
- Regulation
- 21 CFR 868.1170
- Advisory panel
- Anesthesiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code CBZ
FDA has cleared devices under product code CBZ between 1980 and 2002, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 1997
- 1993
- 1992
- 1991
- 1989
- 1986
- 1981
- 1980
Top applicants under product code CBZ
Recent clearances under product code CBZ
- K020967 — TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
- K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR
- K931112 — MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI
- K920061 — HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
- K912030 — CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
- K912428 — PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
- K884228 — CDI(R) 2000 BLOOD GAS MONITOR
- K862114 — KHURI REGIONAL TISSUE PH MONITOR
- K803260 — SENSOMAT MUSCLE/TISSUE PH
- K803014 — SENSOMAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.