CAM · Yoke Assembly, Medical Gas
Anesthesiology · 21 CFR 868.6885 · Class 1
Overview
| Product Code | CAM |
|---|---|
| Device Name | Yoke Assembly, Medical Gas |
| Regulation | 21 CFR 868.6885 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.
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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935283 | YOKE ASSEMBLY MEDICAL GAS | American Gage & Medical, Inc. | Mar 11, 1994 | SESE |
| K851219 | FILL HOSE SAFETY ADAPTER | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| K851217 | PENOX DUAL FLOW MINIFOLD | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| K851216 | PENOX DUAL FEED MANIFOLD | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| K851215 | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| K840326 | GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB | Siemens Elema AB | Jun 7, 1984 | SESE |
| K780365 | OXYGEN/NITROUS OXIDE OUTLET | Spica, Inc. | Mar 30, 1978 | SESE |
| K770426 | OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE | Bel-Med, Inc. | Mar 15, 1977 | SESE |
Top Applicants
- Penox Technologies, Inc. — 4 clearances
- American Gage & Medical, Inc. — 1 clearance
- Bel-Med, Inc. — 1 clearance
- Siemens Elema AB — 1 clearance
- Spica, Inc. — 1 clearance
