T-Handle Adapter, U-Handle & L Handler Adapter
FDA 510(k) K851215 · Penox Technologies, Inc.
510(k) numberK851215
Submission
- Device name
- T-Handle Adapter, U-Handle & L Handler Adapter
- Applicant
- Penox Technologies, Inc.
Pittston, PA, US - Received
- March 26, 1985
- Decision date
- June 18, 1985
- 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 |
| 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 |
More from Bel-Med, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864667 | Penox Hospital BedFNJ · Traditional | 01/21/1987SE |
| K863978 | Portable Liquid Oxygen Unit (Modification)BYJ · Traditional | 12/15/1986SE |
| K862654 | Modified Penox Lift ChairINO · Traditional | 07/18/1986SE |
| K853775 | Penox High Flow ManifoldBYJ · Traditional | 11/29/1985SE |
| K852109 | Penox Performer WheelchairIOR · Traditional | 08/22/1985SE |
| K851218 | Penox Lift ChairINO · Traditional | 06/21/1985SE |
| K851219 | Fill Hose Safety AdapterCAM · Traditional | 06/18/1985SE |
| K851217 | Penox Dual Flow MinifoldCAM · Traditional | 06/18/1985SE |
| K851216 | Penox Dual Feed ManifoldCAM · Traditional | 06/18/1985SE |
Questions and answers
When was T-Handle Adapter, U-Handle & L Handler Adapter cleared by the FDA?
T-Handle Adapter, U-Handle & L Handler Adapter (K851215) received a 510(k) decision of Substantially Equivalent on June 18, 1985, 84 days after the submission was received.
What is the product code of K851215?
The FDA product code is CAM – Yoke Assembly, Medical Gas, a Class I (low risk) device regulated under 21 CFR 868.6885.