CBZ
10 FDA 510(k) clearances · Product code
87 daysmedian time to decision
195 days90th percentile
10clearances measured
FDA profile
- Official device name
- Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1170
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967) | Terumo Cardiovascular Systems Corp. | 2002-06-20 |
| PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR (K970906) | Diametrics Medical, Ltd. | 1997-09-23 |
| MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (K931112) | Puritan Bennett Corp. | 1993-06-01 |
| HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (K920061) | Abbott Laboratories | 1992-03-30 |
| CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (K912030) | 3M Company | 1991-10-30 |
| PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (K912428) | Puritan Bennett Corp. | 1991-08-09 |
| CDI(R) 2000 BLOOD GAS MONITOR (K884228) | Cardiovascular Devices, Inc. | 1989-01-30 |
| KHURI REGIONAL TISSUE PH MONITOR (K862114) | Vascular Technology Incorporated | 1986-06-25 |
| SENSOMAT MUSCLE/TISSUE PH (K803260) | Biochem International, Inc. | 1981-02-02 |
| SENSOMAT (K803014) | Biochem International, Inc. | 1980-12-22 |
Track CBZ automatically
Every clearance here is in the API, with alerts when new ones post.