Transducer, Gas Pressure, Differential
The Transducer, Gas Pressure, Differential is a sensor that measures the pressure difference between two points in a gas system, used in flow measurement and monitoring of pressure gradients across filters, circuits, or airways in respiratory and anesthesia equipment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYR, regulated under 21 CFR 868.2875 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BYR
- Device Class
- FDA class 1
- Regulation Number
- 868.2875
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896718 | BICORE VARIFLEX(R) FLOW TRANSDUCER | Feb 22, 1990 | Substantially Equivalent | Bicore Monitoring Systems |
| K801880 | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS | Aug 14, 1980 | Substantially Equivalent | Medical Measurements, Inc. |
| K790334 | DRAGER ORM | Mar 07, 1979 | Substantially Equivalent | Draeger Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.