CBZ · Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Anesthesiology · 21 CFR 868.1170 · Class 2
Overview
| Product Code | CBZ |
|---|---|
| Device Name | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling |
| Regulation | 21 CFR 868.1170 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Terumo Cardiovascular Systems Corp. | Jun 20, 2002 | SESE |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | Diametrics Medical, Ltd. | Sep 23, 1997 | SESE |
| K931112 | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | Puritan Bennett Corp. | Jun 1, 1993 | SESE |
| K920061 | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | Abbott Laboratories | Mar 30, 1992 | SESE |
| K912030 | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | 3M Company | Oct 30, 1991 | SESE |
| K912428 | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT | Puritan Bennett Corp. | Aug 9, 1991 | SESE |
| K884228 | CDI(R) 2000 BLOOD GAS MONITOR | Cardiovascular Devices, Inc. | Jan 30, 1989 | SESE |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Vascular Technology Incorporated | Jun 25, 1986 | SESE |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | Biochem International, Inc. | Feb 2, 1981 | SESE |
| K803014 | SENSOMAT | Biochem International, Inc. | Dec 22, 1980 | SESE |
Top Applicants
- Puritan Bennett Corp. — 2 clearances
- Biochem International, Inc. — 2 clearances
- Vascular Technology Incorporated — 1 clearance
- Terumo Cardiovascular Systems Corp. — 1 clearance
- Diametrics Medical, Ltd. — 1 clearance
