Gas Sampling Interfaces
FDA 510(k) K943110 · Coast Medical, Inc.
510(k) numberK943110
Submission
- Device name
- Gas Sampling Interfaces
- Applicant
- Coast Medical, Inc.
Orange, CA, US - Received
- June 29, 1994
- Decision date
- August 19, 1994
- 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 |
| 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 |
|---|---|---|
| K952243 | Extension Set/I.V. SetFPK · Traditional | 07/26/1995SE |
| K930929 | Esophageal StethoscopeBZT · Traditional | 03/17/1995SE |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | 12/21/1994SE |
| K943270 | Surface Temperature ProbesFLL · Traditional | 12/05/1994SE |
| K943495 | Disposable Esophageal StethoscopeBZT · Traditional | 09/08/1994SE |
| K930930 | Coast Medical, Inc. Rectal ProbeFLL · Traditional | 02/25/1994SE |
| K925781 | Disposable Cuffed Endotracheal TubeBTR · Traditional | 04/19/1993SE |
| K925855 | Disposable Uncuffed Endotracheal TubeBTR · Traditional | 02/18/1993SE |
| K921077 | Disposable Intubation KitsBTR · Traditional | 08/25/1992SE |
| K921353 | Nasopharyngeal AirwayBTQ · Traditional | 06/11/1992SE |
Questions and answers
When was Gas Sampling Interfaces cleared by the FDA?
Gas Sampling Interfaces (K943110) received a 510(k) decision of Substantially Equivalent on August 19, 1994, 51 days after the submission was received.
What is the product code of K943110?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.