Spiracle Technology Gaseous Oxygen Supply Valve
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K953349 FDA 510(k)
- FDA Product Code
- CBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5870 FDA 510(k)
- Regulation Number
- 868.5870 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A valve, non-rebreathing, that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. It is classified under medical specialty Anesthesiology and device class 2.
Supplied as a reusable device, it received FDA 510(k) clearance (K953349) on February 29, 1996, under regulation number 868.5870 with product code CBP. The device is classified as traditional clearance type and is not a single-use device.
Frequently asked questions
What is the Spirable Technology Gaseous Oxygen Supply Valve used for?
The valve is a non-rebreathing device that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere, and it is classified under the medical specialty of anesthesiology.
Is the Spirable Technology Gaseous Oxygen Supply Valve a single-use or reusable device?
The device is supplied as a reusable device and is not classified as a single-use device, based on its FDA 510(k) clearance documentation.
What regulatory pathway was used for the Spirable Technology Gaseous Oxygen Supply Valve, and when was it cleared?
The device received FDA 510(k) clearance (K953349) on February 29, 1996, under regulation number 868.5870 with product code CBP, and was classified as a traditional clearance type.
What is the device classification and medical specialty for the Spirable Technology Gaseous Oxygen Supply Valve?
The device is classified as a Class 2 medical device and is categorized under the medical specialty of anesthesiology, as indicated in its FDA 510(k) submission and openFDA data.
What is the product code and regulation number associated with the Spirable Technology Gaseous Oxygen Supply Valve?
The device is associated with product code CBP and regulation number 868.5870, as specified in its FDA 510(k) clearance details and openFDA fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE (K953349) — FDA 510(k ..., SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE… - FDA.report, Demand Valves | Ferno
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953349 | Class II | Active |
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Manufacturer
- Manufacturer
- Spiracle Technology
Sources (1)
- FDA 510(k) K953349 24 fields · synced Sep 19, 2026