OSM3 HEMOXIMETER
Device Facts
| Record ID | K853990 |
|---|---|
| Device Name | OSM3 HEMOXIMETER |
| Applicant | Radiometer America, Inc. |
| Product Code | JKS · Clinical Toxicology |
| Decision Date | Dec 30, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3220 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.
