Product Code: BXO FDA class 1 21 CFR 868.2900

Transducer, Gas Pressure

Anesthesiology

The Transducer, Gas Pressure is a sensor that converts gas pressure measurements into electrical signals for display or recording, used in anesthesia machines and ventilators to monitor airway and circuit pressures. 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 BXO, regulated under 21 CFR 868.2900 in the Anesthesiology specialty.

510(k)s
2
FEI Numbers
11
Registration Numbers
11
Unique Applicants
2
Years Active
4

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Basic Information

Product Code
BXO
Device Class
FDA class 1
Regulation Number
868.2900
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 2 510(k) clearances via K numbers.

K Number Device Name
K944027 AG-839PA CO2 MODULE AND ACCESSORIES
K897107 POLY G PHYSIOLOGICAL DATA RECORDER

FEI Numbers

This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.