Product Code: BXA FDA class 1 21 CFR 868.1975

Analyzer, Gas, Water Vapor, Gaseous-Phase

Anesthesiology

The Analyzer, Gas, Water Vapor, Gaseous-Phase is an instrument used to measure the concentration of water vapor in respiratory gas mixtures, providing data relevant to humidification and gas conditioning in anesthesia and respiratory therapy. 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 BXA, regulated under 21 CFR 868.1975 in the Anesthesiology specialty.

510(k)s
2
FEI Numbers
8
Registration Numbers
8
Unique Applicants
2
Years Active
1

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Basic Information

Product Code
BXA
Device Class
FDA class 1
Regulation Number
868.1975
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
K771510 SERVO-PAK MOLEL 0030
K760246 ENDOTRACHEAL T CONNECTOR

FEI Numbers

This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.