Corrugated Flexible Polyethylene & Eva
FDA 510(k) K791821 · Airlife, Inc.
510(k) numberK791821
Submission
- Device name
- Corrugated Flexible Polyethylene & Eva
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- September 14, 1979
- Decision date
- September 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYX – Tubing, Pressure And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5860
- Specialty
- Anesthesiology
Other 510(k)s with product code BYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011134 | Oxygen Supply Tubing, Model 1115BYX · Traditional | Hudson Respiratory Care, Inc. | 06/13/2001SE |
| K955656 | North State Plastics Aerosol TeeBYX · Traditional | North State Plastics, Inc. | 03/06/1996SE |
| K943110 | Gas Sampling InterfacesBYX · Traditional | Coast Medical, Inc. | 08/19/1994SE |
| K935835 | Busse Plastic Tubing Connectors and AccessoriesBYX · Traditional | Busse Hospital Disposables, Inc. | 01/12/1994SE |
| K931043 | MF Ohmeda Style Medical Gas Wall OutletsBYX · Traditional | Medical Fittings, Inc. | 06/01/1993SE |
| K931033 | MF Chemetron Style Medical Gas Wall OutletsBYX · Traditional | Medical Fittings, Inc. | 06/01/1993SE |
| K913422 | Oxygen Tubing, 81503BYX · Traditional | Specialty Packaging Producs, Inc. | 01/30/1992SE |
| K914980 | Hex, Quad, or Rail Block Manifold AccessoriesBYX · Traditional | Medical Fittings, Inc. | 01/21/1992SE |
| K912763 | Ohmeda Style Check Units (Female Couplers)BYX · Traditional | Medical Fittings, Inc. | 10/15/1991SE |
| K905091 | Various Male Quick Connects.BYX · Traditional | Medical Fittings, Inc. | 03/04/1991SE |
More from Medical Fittings, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K834077 | Single Use Nebulizer-Adjust-Air EntrainCAF · Traditional | 12/12/1983SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K833197 | Trach Swive/ConnectorBTR · Traditional | 10/28/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
Questions and answers
When was Corrugated Flexible Polyethylene & Eva cleared by the FDA?
Corrugated Flexible Polyethylene & Eva (K791821) received a 510(k) decision of Substantially Equivalent on September 26, 1979, 12 days after the submission was received.
What is the product code of K791821?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.