PICO SMOKERLYZER, MODEL EC-50
Device Facts
| Record ID | K000962 |
|---|---|
| Device Name | PICO SMOKERLYZER, MODEL EC-50 |
| Applicant | Bedfont Scientific, Ltd. |
| Product Code | CCJ · Anesthesiology |
| Decision Date | Apr 20, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.1430 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.