FOG · Hood, Oxygen, Infant
Anesthesiology · 21 CFR 868.5700 · Class 1
Overview
| Product Code | FOG |
|---|---|
| Device Name | Hood, Oxygen, Infant |
| Regulation | 21 CFR 868.5700 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973128 | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | Olympus America, Inc. | Nov 18, 1997 | SESE |
| K962182 | BURLEW INFANT HOOD | Promedic, Inc. | Jul 15, 1996 | SESE |
| K955482 | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | Advantage Medical Services, Inc. | Jan 30, 1996 | SESE |
| K830781 | ENDO-GUARD | Jayco Pharmaceuticals | Mar 31, 1983 | SESE |
| K792144 | DISPOSA-HOOD | Utah Medical Products, Inc. | Dec 5, 1979 | SESE |
| K791861 | OXYGEN HOODS | Ann Arbor Plastics, Inc. | Oct 4, 1979 | SESE |
| K790860 | RT-HOOD | Plastics Supplies & Products | May 29, 1979 | SESE |
| K780220 | HOOD, INFANT OXYGEN | Shiley, Inc. | Apr 10, 1978 | SESE |
| K770754 | DUODENOSCOPE, MOLEL TX-6 | American Cystocope Makers, Inc. | Apr 28, 1977 | SESE |
Top Applicants
- Utah Medical Products, Inc. — 1 clearance
- Shiley, Inc. — 1 clearance
- Promedic, Inc. — 1 clearance
- Plastics Supplies & Products — 1 clearance
- Olympus America, Inc. — 1 clearance
