Maxi-Use O2 Device
FDA 510(k) K861325 · B & F Medical Products, Inc.
510(k) numberK861325
Submission
- Device name
- Maxi-Use O2 Device
- Applicant
- B & F Medical Products, Inc.
Toledo, OH, US - Received
- April 9, 1986
- Decision date
- September 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K220591 | ProximaNFB · Traditional | Dynasthetics, LLC | 12/15/2022SE |
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| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
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| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
More from Chad Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942645 | B&F Medical Oxygen Reg Mecical Oxy Compress Gas RegBXH · Traditional | 07/27/1994SE |
| K920573 | Cannula Nasal OxygenCAT · Traditional | 08/11/1992SE |
| K913501 | Tracheostomy MaskBYG · Traditional | 01/13/1992SE |
| K861054 | Disposable Rescue Breathing DeviceCAE · Traditional | 04/09/1986SE |
| K853004 | Portable Oxygen UnitCAW · Traditional | 08/29/1985SE |
| K843691 | Portable Oxygen UnitCAW · Traditional | 11/07/1984SE |
| K823532 | Stock #64091-PEDIATRIC Oxygen MaskBYG · Traditional | 01/05/1983SE |
| K811404 | TravelaireCCQ · Traditional | 06/09/1981SE |
| K802644 | Emerg. Oxygen Kit #65350 & #65399 CaseCAN · Traditional | 12/22/1980SE |
| K802646 | Hand Percussor Cup #65210BYI · Traditional | 11/12/1980SE |
Questions and answers
When was Maxi-Use O2 Device cleared by the FDA?
Maxi-Use O2 Device (K861325) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 153 days after the submission was received.
What is the product code of K861325?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.