Incent-O-Neb
FDA 510(k) K781731 · B & F Medical Products, Inc.
510(k) numberK781731
Submission
- Device name
- Incent-O-Neb
- Applicant
- B & F Medical Products, Inc.
Mchenry, IL, US - Received
- October 12, 1978
- Decision date
- December 5, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
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| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
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| 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 |
| K861325 | Maxi-Use O2 DeviceNFB · Traditional | 09/09/1986SE |
| 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 |
Questions and answers
When was Incent-O-Neb cleared by the FDA?
Incent-O-Neb (K781731) received a 510(k) decision of Substantially Equivalent on December 5, 1978, 54 days after the submission was received.
What is the product code of K781731?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.