Gas Supply Manifold Siemens-Elema AB
FDA 510(k) K840326 · Siemens Elema AB
510(k) numberK840326
Submission
- Device name
- Gas Supply Manifold Siemens-Elema AB
- Applicant
- Siemens Elema AB
Mchenry, IL, US - Received
- January 25, 1984
- Decision date
- June 7, 1984
- 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 |
| K780365 | Oxygen/Nitrous Oxide OutletCAM · Traditional | Spica, Inc. | 03/30/1978SE |
| K770426 | Oxygen Manifold Systems, Nitrous OxideCAM · Traditional | Bel-Med, Inc. | 03/15/1977SE |
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Questions and answers
When was Gas Supply Manifold Siemens-Elema AB cleared by the FDA?
Gas Supply Manifold Siemens-Elema AB (K840326) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 134 days after the submission was received.
What is the product code of K840326?
The FDA product code is CAM – Yoke Assembly, Medical Gas, a Class I (low risk) device regulated under 21 CFR 868.6885.