Yoke Assembly Medical Gas
FDA 510(k) K935283 · American Gage & Medical, Inc.
510(k) numberK935283
Submission
- Device name
- Yoke Assembly Medical Gas
- Applicant
- American Gage & Medical, Inc.
San Francisco, CA, US - Received
- November 3, 1993
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAM – Yoke Assembly, Medical Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6885
- Specialty
- Anesthesiology
Other 510(k)s with product code CAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851219 | Fill Hose Safety AdapterCAM · Traditional | Penox Technologies, Inc. | 06/18/1985SE |
| K851217 | Penox Dual Flow MinifoldCAM · Traditional | Penox Technologies, Inc. | 06/18/1985SE |
| K851216 | Penox Dual Feed ManifoldCAM · Traditional | Penox Technologies, Inc. | 06/18/1985SE |
| K851215 | T-Handle Adapter, U-Handle & L Handler AdapterCAM · Traditional | Penox Technologies, Inc. | 06/18/1985SE |
| K840326 | Gas Supply Manifold Siemens-Elema ABCAM · Traditional | Siemens Elema AB | 06/07/1984SE |
| K780365 | Oxygen/Nitrous Oxide OutletCAM · Traditional | Spica, Inc. | 03/30/1978SE |
| K770426 | Oxygen Manifold Systems, Nitrous OxideCAM · Traditional | Bel-Med, Inc. | 03/15/1977SE |
Questions and answers
When was Yoke Assembly Medical Gas cleared by the FDA?
Yoke Assembly Medical Gas (K935283) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 128 days after the submission was received.
What is the product code of K935283?
The FDA product code is CAM – Yoke Assembly, Medical Gas, a Class I (low risk) device regulated under 21 CFR 868.6885.