SFO · Electrode Measurement, Drain Effluent Ph
Clinical Chemistry · 21 CFR 862.1120 · Class 2
Overview
| Product Code | SFO |
|---|---|
| Device Name | Electrode Measurement, Drain Effluent Ph |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243965 | Origin | Nerv Technology Inc. (D.B.A.) Fluidai Medical | Aug 21, 2025 | SESE |
Top Applicants
- Nerv Technology Inc. (D.B.A.) Fluidai Medical — 1 clearance
