PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
Device Facts
| Record ID | K912428 |
|---|---|
| Device Name | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT |
| Applicant | Puritan Bennett Corp. |
| Product Code | CBZ · Anesthesiology |
| Decision Date | Aug 9, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1170 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
