Misty Ox Dispos. Nebulizer
FDA 510(k) K841469 · Medical Molding Corp. of America
510(k) numberK841469
Submission
- Device name
- Misty Ox Dispos. Nebulizer
- Applicant
- Medical Molding Corp. of America
Newport Beach, CA, US - Received
- April 9, 1984
- Decision date
- April 24, 1984
- 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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| 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 |
|---|---|---|
| K923754 | Misty Ox Laminar Diffuser HumidifierBTT · Traditional | 12/07/1992SE |
Questions and answers
When was Misty Ox Dispos. Nebulizer cleared by the FDA?
Misty Ox Dispos. Nebulizer (K841469) received a 510(k) decision of Substantially Equivalent on April 24, 1984, 15 days after the submission was received.
What is the product code of K841469?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.