Oxygen Supply Tubing, Model 1115
FDA 510(k) K011134 · Hudson Respiratory Care, Inc.
510(k) numberK011134
Submission
- Device name
- Oxygen Supply Tubing, Model 1115
- Applicant
- Hudson Respiratory Care, Inc.
Temecula, CA, US - Received
- April 13, 2001
- Decision date
- June 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K031383 | Model 780BTT · Special | 07/07/2003SE |
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | 06/13/2001SE |
| K010402 | Smooth-Flo CircuitBTT · Special | 03/14/2001SE |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60BTT · Traditional | 11/03/2000SE |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40…BTT · Traditional | 05/24/2000SE |
| K994352 | Side Draft Neb-U-Mist Nebulizer, Model 41896CAF · Traditional | 03/22/2000SE |
| K964719 | Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorBTM · Traditional | 02/21/1997SE |
| K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaCCK · Traditional | 09/10/1996SE |
| K961914 | Bacteria/Viral FilterCAH · Traditional | 08/14/1996SE |
| K955645 | Cath-GuideBSY · Traditional | 03/12/1996SE |
Questions and answers
When was Oxygen Supply Tubing, Model 1115 cleared by the FDA?
Oxygen Supply Tubing, Model 1115 (K011134) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 61 days after the submission was received.
What is the product code of K011134?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.