Tent, Oxygen, Electrically Powered
The Tent, Oxygen, Electrically Powered is an electrically powered enclosure placed over a patient, typically a child, to deliver a controlled oxygen-enriched atmosphere for respiratory therapy without requiring a mask directly on the face. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYK, regulated under 21 CFR 868.5710 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.
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Basic Information
- Product Code
- BYK
- Device Class
- FDA class 2
- Regulation Number
- 868.5710
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | Mar 01, 1995 | Substantially Equivalent | Allied Healthcare Products, Inc. |
| K882817 | LUNG DIFFUSION GAS MIXTURE | Aug 15, 1988 | Substantially Equivalent | Swisco, Inc. |
| K813235 | DISS FEMALE AIR ADAPTOR | Dec 08, 1981 | Substantially Equivalent | Timeter Instrument Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.