ABL SYSTEM 620
Device Facts
| Record ID | K935121 |
|---|---|
| Device Name | ABL SYSTEM 620 |
| Applicant | Radiometer America, Inc. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | May 27, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
