BYL · Tent, Oxygen
Anesthesiology · 21 CFR 868.5700 · Class 1
Overview
| Product Code | BYL |
|---|---|
| Device Name | Tent, Oxygen |
| 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 (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935126 | NASCOR IGLOO | Nascor Pty. , Ltd. | Oct 18, 1994 | SESE |
| K905627 | NASCOR OXYDOME | Nascor Pty. , Ltd. | Jun 3, 1991 | SESE |
| K896608 | SPAG PAK | Viratek, Inc. | Apr 9, 1990 | SESE |
| K895866 | DIRD INGANT O2 (BIO 2 HOOD) | Bird Products Corp. | Oct 27, 1989 | SESE |
| K893714 | KEYSTONE OXYGEN TENT | Keystone Veterinary Supplies, Inc. | Aug 21, 1989 | SESE |
| K893713 | NOVA OXYGEN TENT | Nova Health Systems, Inc. | Aug 21, 1989 | SESE |
| K882396 | AEROSOL DELIVERY HOOD | Viratek, Inc. | Aug 1, 1988 | SESE |
| K851666 | MEDI-COMP NEONATAL OXYGEN HOOD | Medicomp, Inc. | Aug 6, 1985 | SESE |
| K852345 | SEA-LONG NECKSEAL & HOOD | Safety Sea Systems, Inc. | Jun 20, 1985 | SESE |
| K820640 | HOO2D SEAT-INFANT | Dhd Medical Products Div. Diemolding Corp. | Mar 26, 1982 | SESE |
| K802653 | MEDIUM SIZE OXYGEN HOOD #1547 | Ann Arbor Plastics, Inc. | Nov 24, 1980 | SESE |
Top Applicants
- Viratek, Inc. — 2 clearances
- Nascor Pty. , Ltd. — 2 clearances
- Safety Sea Systems, Inc. — 1 clearance
- Nova Health Systems, Inc. — 1 clearance
- Medicomp, Inc. — 1 clearance
