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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
