Mask, Oxygen, Non-Rebreathing
Non-Rebreathing Oxygen Mask is a respiratory therapy device placed over the patient's nose and mouth to deliver high-concentration oxygen from a supply source, incorporating a one-way valve system that prevents the patient from inhaling exhaled air, ensuring delivery of near-pure oxygen. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGB, regulated under 21 CFR 868.5570, within the Anesthesiology medical specialty.
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Basic Information
- Product Code
- KGB
- Device Class
- FDA class 1
- Regulation Number
- 868.5570
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970688 | POCKET RESCUE | Sep 26, 1997 | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. |
| K960401 | ULTIMATE SEAL | Jun 20, 1996 | Substantially Equivalent | Hans Rudolph, Inc. |
| K941336 | COMBO MASK | Sep 09, 1994 | Substantially Equivalent | Gam Industries, Inc. |
| K935917 | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | Feb 04, 1994 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K932347 | COMPACT MASK | Jan 10, 1994 | Substantially Equivalent | Vital Signs, Inc. |
| K933583 | NONREBREATHING VALVE | Jan 03, 1994 | Substantially Equivalent | Hans Rudolph, Inc. |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Dec 02, 1993 | Substantially Equivalent | Laerdal Medical Corp. |
| K930336 | PROFAST(R)-DENTURE ADHESIVE CREAM | Aug 24, 1993 | Substantially Equivalent | Fittydent-Altwirth & Schmitt GmbH |
| K913164 | NON REBREATHING MASK | Jan 15, 1992 | Substantially Equivalent | Specialty Packaging Producs, Inc. |
| K883766 | MOUTH-TO-MASK VENTILATORY ADJUNCT | Oct 21, 1988 | Substantially Equivalent | Medic One |
| K790162 | OXYGEN MASK, CONCENTRATION AEROSOL MASK | Apr 20, 1979 | Substantially Equivalent | Airlife, Inc. |
| K790161 | OXYGEN MASK W/RESERVOIR BAG | Apr 20, 1979 | Substantially Equivalent | Airlife, Inc. |
| K781414 | MASK, OXYGEN, NONBREATHING | Sep 07, 1978 | Substantially Equivalent | Vitalab Products Corp. |
FEI Numbers
This FDA classification entry is associated with 151 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 151 registration numbers. Click on an entry to view related FDA registrations.