Identifiers
- 510(k) Number
- K833197 FDA 510(k)
- FDA Product Code
- BTR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5730 FDA 510(k)
- Regulation Number
- 868.5730 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a tracheal tube with or without a connector, classified as a tube, tracheal (W/Wo connector) under FDA device classification. It is intended for use in anesthesiology applications as indicated by the advisory committee and medical specialty description.
The device received traditional 510(k) clearance (K833197) on October 28, 1983, and is classified as a Class II medical device. It is manufactured by Airlife, Inc. and is not a third-party reviewed device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833197 | Class II | Active |
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Manufacturer
- Manufacturer
- Airlife, Inc.
Sources (1)
- FDA 510(k) K833197 24 fields · synced Sep 21, 2026