Pulmo-Aide Model 5610D
FDA 510(k) K854520 · The Devilbiss Co.
510(k) numberK854520
Submission
- Device name
- Pulmo-Aide Model 5610D
- Applicant
- The Devilbiss Co.
Somerset, PA, US - Received
- November 12, 1985
- Decision date
- December 9, 1985
- 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
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| K961894 | Mdi TutorCCQ · Traditional | Mdi Tutor, Inc. | 08/14/1996SE |
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| 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 |
|---|---|---|
| K874041 | Devilbiss Model 8500DCAF · Traditional | 12/23/1987SE |
| K872094 | Vacu-AideJCX · Traditional | 10/15/1987SE |
| K872826 | Ultra-Neb 99 Ultrasonic NebulizerCAF · Traditional | 09/04/1987SE |
| K872470 | DEVO/MC44 Oxygen ConcentratorCAW · Traditional | 08/03/1987SE |
| K852209 | DEVO/MC29 Oxygen Concentrator MC29DCAW · Traditional | 06/24/1985SE |
| K851695 | Ultra-Neb 100 Ultrasonic Nebulizer · Traditional | 06/05/1985SE |
| K830174 | De VO/44 Oxygen Concentrator #444CAW · Traditional | 02/17/1983SE |
| K801526 | Surveyor I, Respiratory Computer SystemBZC · Traditional | 07/21/1980SE |
| K792385 | Devo Oxygen Concentrator, Model 955CAW · Traditional | 12/05/1979SE |
| K781073 | Pulmo-SonicCCQ · Traditional | 09/27/1978SE |
Questions and answers
When was Pulmo-Aide Model 5610D cleared by the FDA?
Pulmo-Aide Model 5610D (K854520) received a 510(k) decision of Substantially Equivalent on December 9, 1985, 27 days after the submission was received.
What is the product code of K854520?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.