Gauge, Gas Pressure, Cylinder/Pipeline
The Gauge, Gas Pressure, Cylinder/Pipeline is an instrument used to measure and display the pressure of medical gas within storage cylinders or distribution pipelines, ensuring safe and adequate gas supply during clinical use. 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 BXH, regulated under 21 CFR 868.2610 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BXH
- Device Class
- FDA class 1
- Regulation Number
- 868.2610
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | Jul 27, 1994 | Substantially Equivalent | B & F Medical Products, Inc. |
| K853040 | PRESSURE GAUGE | Oct 10, 1985 | Substantially Equivalent | Erie Medical |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent | Hospitak, Inc. |
| K770614 | MONITOR, GAS MANIFOLD | Apr 07, 1977 | Substantially Equivalent | Dynatech Cryomedical Co. |
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.