BXO · Transducer, Gas Pressure
Anesthesiology · 21 CFR 868.2900 · Class 1
Overview
| Product Code | BXO |
|---|---|
| Device Name | Transducer, Gas Pressure |
| Regulation | 21 CFR 868.2900 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944027 | AG-839PA CO2 MODULE AND ACCESSORIES | Nihon Kohden America, Inc. | Aug 31, 1994 | SESE |
| K897107 | POLY G PHYSIOLOGICAL DATA RECORDER | Cns, Inc. | Mar 12, 1990 | SESE |
Top Applicants
- Nihon Kohden America, Inc. — 1 clearance
- Cns, Inc. — 1 clearance
