Hood, Oxygen, Infant
The Infant Oxygen Hood is a clear plastic enclosure placed over an infant's head to deliver supplemental oxygen at controlled concentrations, used in neonatal respiratory care. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOG, regulated under 21 CFR 868.5700 in the Anesthesiology specialty.
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Basic Information
- Product Code
- FOG
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973128 | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | Nov 18, 1997 | Substantially Equivalent | Olympus America, Inc. |
| K962182 | BURLEW INFANT HOOD | Jul 15, 1996 | Substantially Equivalent | Promedic, Inc. |
| K955482 | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | Jan 30, 1996 | Substantially Equivalent | Advantage Medical Services, Inc. |
| K830781 | ENDO-GUARD | Mar 31, 1983 | Substantially Equivalent | Jayco Pharmaceuticals |
| K792144 | DISPOSA-HOOD | Dec 05, 1979 | Substantially Equivalent | Utah Medical Products, Inc. |
| K791861 | OXYGEN HOODS | Oct 04, 1979 | Substantially Equivalent | Ann Arbor Plastics, Inc. |
| K790860 | RT-HOOD | May 29, 1979 | Substantially Equivalent | Plastics Supplies & Products |
| K780220 | HOOD, INFANT OXYGEN | Apr 10, 1978 | Substantially Equivalent | Shiley, Inc. |
| K770754 | DUODENOSCOPE, MOLEL TX-6 | Apr 28, 1977 | Substantially Equivalent | American Cystocope Makers, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.