Oxygen, Air, Vacuum & Nitrous-Oxide Couplers
FDA 510(k) K904757 · Medical Fittings, Inc.
510(k) numberK904757
Submission
- Device name
- Oxygen, Air, Vacuum & Nitrous-Oxide Couplers
- Applicant
- Medical Fittings, Inc.
Northampton, PA, US - Received
- October 19, 1990
- Decision date
- October 31, 1990
- 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 |
|---|---|---|
| K931043 | MF Ohmeda Style Medical Gas Wall OutletsBYX · Traditional | 06/01/1993SE |
| K931033 | MF Chemetron Style Medical Gas Wall OutletsBYX · Traditional | 06/01/1993SE |
| K920360 | Timox Oxygen TimerBXP · Traditional | 08/03/1992SE |
| K914980 | Hex, Quad, or Rail Block Manifold AccessoriesBYX · Traditional | 01/21/1992SE |
| K912763 | Ohmeda Style Check Units (Female Couplers)BYX · Traditional | 10/15/1991SE |
| K905091 | Various Male Quick Connects.BYX · Traditional | 03/04/1991SE |
| K905094 | Schrader Oxygen/Air Vac&Nitr-Oxide Male Quick ConnBYX · Traditional | 11/20/1990SE |
| K904702 | Medi Fitt/Oxequip Oxygen/Air Male Quick ConnectsBYX · Traditional | 10/31/1990SE |
| K904701 | Medi Fitt/Ohmeda Oxy/Air/Vac&Nit-Oxi Male QK ConnBYX · Traditional | 10/31/1990SE |
| K904337 | Oxygen, Air, Vacuum and Nitrous-Oxide Male Conn.BYX · Traditional | 10/04/1990SE |
Questions and answers
When was Oxygen, Air, Vacuum & Nitrous-Oxide Couplers cleared by the FDA?
Oxygen, Air, Vacuum & Nitrous-Oxide Couplers (K904757) received a 510(k) decision of Substantially Equivalent on October 31, 1990, 12 days after the submission was received.
What is the product code of K904757?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.