Ohmeda Style Check Units (Female Couplers)
FDA 510(k) K912763 · Medical Fittings, Inc.
510(k) numberK912763
Submission
- Device name
- Ohmeda Style Check Units (Female Couplers)
- Applicant
- Medical Fittings, Inc.
Northampton, PA, US - Received
- June 24, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K905091 | Various Male Quick Connects.BYX · Traditional | Medical Fittings, Inc. | 03/04/1991SE |
| K905094 | Schrader Oxygen/Air Vac&Nitr-Oxide Male Quick ConnBYX · Traditional | Medical Fittings, Inc. | 11/20/1990SE |
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 |
| K905091 | Various Male Quick Connects.BYX · Traditional | 03/04/1991SE |
| K905094 | Schrader Oxygen/Air Vac&Nitr-Oxide Male Quick ConnBYX · Traditional | 11/20/1990SE |
| K904757 | Oxygen, Air, Vacuum & Nitrous-Oxide CouplersBYX · Traditional | 10/31/1990SE |
| 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 Ohmeda Style Check Units (Female Couplers) cleared by the FDA?
Ohmeda Style Check Units (Female Couplers) (K912763) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 113 days after the submission was received.
What is the product code of K912763?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.