JED · Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
Anesthesiology · 21 CFR 868.1120 · Class 3
Overview
| Product Code | JED |
|---|---|
| Device Name | Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling |
| Regulation | 21 CFR 868.1120 |
| Device Class | Class 3 |
| Review Panel | Anesthesiology |
Identification
An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.
Classification Rationale
Class III (premarket approval).
Cleared Devices (0)
No cleared devices on record.
