BXH · Gauge, Gas Pressure, Cylinder/Pipeline
Anesthesiology · 21 CFR 868.2610 · Class 1
Overview
| Product Code | BXH |
|---|---|
| Device Name | Gauge, Gas Pressure, Cylinder/Pipeline |
| Regulation | 21 CFR 868.2610 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | B & F Medical Products, Inc. | Jul 27, 1994 | SESE |
| K853040 | PRESSURE GAUGE | Erie Medical | Oct 10, 1985 | SESE |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Hospitak, Inc. | Sep 19, 1984 | SESE |
| K770614 | MONITOR, GAS MANIFOLD | Dynatech Cryomedical Co. | Apr 7, 1977 | SESE |
Top Applicants
- B & F Medical Products, Inc. — 1 clearance
- Dynatech Cryomedical Co. — 1 clearance
- Erie Medical — 1 clearance
- Hospitak, Inc. — 1 clearance
