Tent, Oxygen
The Tent, Oxygen is a non-powered enclosure used to provide supplemental oxygen to patients, particularly children, by surrounding them with an oxygen-enriched environment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYL, regulated under 21 CFR 868.5700 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BYL
- Device Class
- FDA class 1
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935126 | NASCOR IGLOO | Oct 18, 1994 | Substantially Equivalent | Nascor Pty. , Ltd. |
| K905627 | NASCOR OXYDOME | Jun 03, 1991 | Substantially Equivalent | Nascor Pty. , Ltd. |
| K896608 | SPAG PAK | Apr 09, 1990 | Substantially Equivalent | Viratek, Inc. |
| K895866 | DIRD INGANT O2 (BIO 2 HOOD) | Oct 27, 1989 | Substantially Equivalent | Bird Products Corp. |
| K893714 | KEYSTONE OXYGEN TENT | Aug 21, 1989 | Substantially Equivalent | Keystone Veterinary Supplies, Inc. |
| K893713 | NOVA OXYGEN TENT | Aug 21, 1989 | Substantially Equivalent | Nova Health Systems, Inc. |
| K882396 | AEROSOL DELIVERY HOOD | Aug 01, 1988 | Substantially Equivalent | Viratek, Inc. |
| K851666 | MEDI-COMP NEONATAL OXYGEN HOOD | Aug 06, 1985 | Substantially Equivalent | Medicomp, Inc. |
| K852345 | SEA-LONG NECKSEAL & HOOD | Jun 20, 1985 | Substantially Equivalent | Safety Sea Systems, Inc. |
| K820640 | HOO2D SEAT-INFANT | Mar 26, 1982 | Substantially Equivalent | Dhd Medical Products Div. Diemolding Corp. |
| K802653 | MEDIUM SIZE OXYGEN HOOD #1547 | Nov 24, 1980 | Substantially Equivalent | Ann Arbor Plastics, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.