Oxygen Connecting Tube
FDA 510(k) K830988 · Medovations, Inc.
510(k) numberK830988
Submission
- Device name
- Oxygen Connecting Tube
- Applicant
- Medovations, Inc.
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- May 3, 1983
- 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
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| K912763 | Ohmeda Style Check Units (Female Couplers)BYX · Traditional | Medical Fittings, Inc. | 10/15/1991SE |
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Questions and answers
When was Oxygen Connecting Tube cleared by the FDA?
Oxygen Connecting Tube (K830988) received a 510(k) decision of Substantially Equivalent on May 3, 1983, 35 days after the submission was received.
What is the product code of K830988?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.