BYR · Transducer, Gas Pressure, Differential
Anesthesiology · 21 CFR 868.2875 · Class 1
Overview
| Product Code | BYR |
|---|---|
| Device Name | Transducer, Gas Pressure, Differential |
| Regulation | 21 CFR 868.2875 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896718 | BICORE VARIFLEX(R) FLOW TRANSDUCER | Bicore Monitoring Systems | Feb 22, 1990 | SESE |
| K801880 | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS | Medical Measurements, Inc. | Aug 14, 1980 | SESE |
| K790334 | DRAGER ORM | Draeger Medical, Inc. | Mar 7, 1979 | SESE |
Top Applicants
- Medical Measurements, Inc. — 1 clearance
- Draeger Medical, Inc. — 1 clearance
- Bicore Monitoring Systems — 1 clearance
