Product code KGB
- Device name
- Mask, Oxygen, Non-Rebreathing
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5570
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970688 | POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| K960401 | ULTIMATE SEAL | Hans Rudolph, Inc. | 1996-06-20 |
| K941336 | COMBO MASK | Gam Industries, Inc. | 1994-09-09 |
| K935917 | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-02-04 |
| K932347 | COMPACT MASK | Vital Signs, Inc. | 1994-01-10 |
| K933583 | NONREBREATHING VALVE | Hans Rudolph, Inc. | 1994-01-03 |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Laerdal Medical Corp. | 1993-12-02 |
| K930336 | PROFAST(R)-DENTURE ADHESIVE CREAM | Fittydent-Altwirth & Schmitt GmbH | 1993-08-24 |
| K913164 | NON REBREATHING MASK | Specialty Packaging Producs, Inc. | 1992-01-15 |
| K883766 | MOUTH-TO-MASK VENTILATORY ADJUNCT | Medic One | 1988-10-21 |
| K790161 | OXYGEN MASK W/RESERVOIR BAG | Airlife, Inc. | 1979-04-20 |
| K790162 | OXYGEN MASK, CONCENTRATION AEROSOL MASK | Airlife, Inc. | 1979-04-20 |
| K781414 | MASK, OXYGEN, NONBREATHING | Vitalab Products Corp. | 1978-09-07 |
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| 09341394027183 | AeroShield CPR Face Shield | AERO HEALTHCARE (US), LLC | 2026-04-02 |
| 10197344011483 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344009602 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344009619 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344011476 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344011506 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344011810 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
| 10197344042180 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2025-11-14 |
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| 10190752116320 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |