Travelaire
FDA 510(k) K811404 · B & F Medical Products, Inc.
510(k) numberK811404
Submission
- Device name
- Travelaire
- Applicant
- B & F Medical Products, Inc.
Mchenry, IL, US - Received
- May 18, 1981
- Decision date
- June 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5640
- Specialty
- Anesthesiology
Other 510(k)s with product code CCQ
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|---|---|---|---|
| K972397 | Ez SprayCCQ · Traditional | Intertex Research, Inc. | 09/23/1997SE |
| K964956 | E-Z Spacer Mask (Small)CCQ · Traditional | Airpharma, LLC | 04/23/1997SE |
| K961894 | Mdi TutorCCQ · Traditional | Mdi Tutor, Inc. | 08/14/1996SE |
| K961455 | Medshield/AerochamberCCQ · Traditional | Diemolding Corp. | 07/25/1996SE |
| K960593 | Smartmist Asthma Managment System, Smartmist, Model Number SM-100/SMARTMIST Spirometry…CCQ · Traditional | Aradigm Corp. | 05/10/1996SE |
| K922033 | Saline Solution- SterileCCQ · Traditional | Trinity Laboratories, Inc. | 07/21/1992SE |
| K900576 | Modified Aerochamber with MaskCCQ · Traditional | Monaghan Medical Corp. | 05/13/1991SE |
| K900557 | Modified Aerochamber M.V. Aerosol Holding ChamberCCQ · Traditional | Monaghan Medical Corp. | 04/10/1991SE |
| K895115 | Frank Inhaler Thermal SCCQ · Traditional | Buttner-Frank GmbH | 05/18/1990SE |
| K894215 | Evolution UltrasonicCCQ · Traditional | Medical Industries America, Inc. | 04/16/1990SE |
More from Medical Industries America, 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 |
| 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 |
| 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 Travelaire cleared by the FDA?
Travelaire (K811404) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 22 days after the submission was received.
What is the product code of K811404?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.