Oxygen Manifold Systems, Nitrous Oxide
FDA 510(k) K770426 · Bel-Med, Inc.
510(k) numberK770426
Submission
- Device name
- Oxygen Manifold Systems, Nitrous Oxide
- Applicant
- Bel-Med, Inc.
Mchenry, IL, US - Received
- March 7, 1977
- Decision date
- March 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K935283 | Yoke Assembly Medical GasCAM · Traditional | American Gage & Medical, Inc. | 03/11/1994SE |
| 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 |
More from Spica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821801 | Norsen DebriderGED · Traditional | 07/28/1982SE |
Questions and answers
When was Oxygen Manifold Systems, Nitrous Oxide cleared by the FDA?
Oxygen Manifold Systems, Nitrous Oxide (K770426) received a 510(k) decision of Substantially Equivalent on March 15, 1977, 8 days after the submission was received.
What is the product code of K770426?
The FDA product code is CAM – Yoke Assembly, Medical Gas, a Class I (low risk) device regulated under 21 CFR 868.6885.