Medipart Radioaerosol Delivery Sys for Ultravent S
FDA 510(k) K854551 · Medipart Jerry Alexander
510(k) numberK854551
Submission
- Device name
- Medipart Radioaerosol Delivery Sys for Ultravent S
- Applicant
- Medipart Jerry Alexander
Cary, IL, US - Received
- November 13, 1985
- Decision date
- December 19, 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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| 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 |
|---|---|---|
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | 02/26/1990SE |
| K896125 | Medipart Disposable XENON-133 Rebreathing MP-0133MIYT · Traditional | 02/01/1990SE |
| K896476 | Disp. Radioaerosol Kit (MP-400-M) to Fit ShieldIYT · Traditional | 01/22/1990SE |
| K896475 | Disp. Radioaerosol Kit (MP-400) to Fit Lead ShieldIYT · Traditional | 01/22/1990SE |
| K896124 | Medipart Disposable XENON-133 Rebreathing MP-0133IYT · Traditional | 01/22/1990SE |
| K894138 | Medipart Disposable Aerosol System MP-070-PTDCAF · Traditional | 09/26/1989SE |
| K893532 | Resubmitted Radioaerosol Cont. System MP-963CBN · Traditional | 08/21/1989SE |
| K862795 | MP-070-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862794 | MP-070 Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862793 | MP-066-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
Questions and answers
When was Medipart Radioaerosol Delivery Sys for Ultravent S cleared by the FDA?
Medipart Radioaerosol Delivery Sys for Ultravent S (K854551) received a 510(k) decision of Substantially Equivalent on December 19, 1985, 36 days after the submission was received.
What is the product code of K854551?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.