Modified Aerochamber with Mask
FDA 510(k) K900576 · Monaghan Medical Corp.
510(k) numberK900576
Submission
- Device name
- Modified Aerochamber with Mask
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- February 7, 1990
- Decision date
- May 13, 1991
- 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 |
| K961455 | Medshield/AerochamberCCQ · Traditional | Diemolding Corp. | 07/25/1996SE |
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| K922033 | Saline Solution- SterileCCQ · Traditional | Trinity Laboratories, Inc. | 07/21/1992SE |
| 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 |
| K894555 | Pari Inhalierboy Type 37.80 Double InsulatedCCQ · Traditional | Dura Pharmaceuticals, Inc. | 01/24/1990SE |
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Questions and answers
When was Modified Aerochamber with Mask cleared by the FDA?
Modified Aerochamber with Mask (K900576) received a 510(k) decision of Substantially Equivalent on May 13, 1991, 460 days after the submission was received.
What is the product code of K900576?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.