Product Code: BYR FDA class 1 21 CFR 868.2875

Transducer, Gas Pressure, Differential

Anesthesiology

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.

510(k)s
3
FEI Numbers
4
Registration Numbers
4
Unique Applicants
3
Years Active
11

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 3 510(k) clearances via K numbers.

K Number Device Name
K896718 BICORE VARIFLEX(R) FLOW TRANSDUCER
K801880 MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
K790334 DRAGER ORM

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.