Cirrus Drug Nebulizer MK III
FDA 510(k) K860875 · Dhd Medical Products Div. Diemolding Corp.
510(k) numberK860875
Submission
- Device name
- Cirrus Drug Nebulizer MK III
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
Canastota, NY, US - Received
- February 25, 1986
- Decision date
- March 20, 1986
- 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 |
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| K895115 | Frank Inhaler Thermal SCCQ · Traditional | Buttner-Frank GmbH | 05/18/1990SE |
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More from Medical Industries America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883988 | Non-Rebreathing Tee Piece (NRTP)CBP · Traditional | 10/07/1988SE |
| K881935 | Microcirrus Medical NebulizerCAF · Traditional | 06/22/1988SE |
| K881178 | CuffcheckBSK · Traditional | 04/14/1988SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | 03/09/1988SE |
| K874047 | AsthmakitCAF · Traditional | 02/29/1988SE |
| K873447 | Disposable Condensate Bottle for 7200 VentilatorBYH · Traditional | 10/30/1987SE |
| K860885 | Straight Connectors, 15MM, 30MM & 19MMBZA · Traditional | 03/20/1986SE |
| K860882 | Disposable CatheterBZA · Traditional | 03/20/1986SE |
| K860880 | Ventilator Circuits (Various Types)BZO · Traditional | 03/20/1986SE |
| K860879 | Disposable Ventilator CircuitsBZO · Traditional | 03/20/1986SE |
Questions and answers
When was Cirrus Drug Nebulizer MK III cleared by the FDA?
Cirrus Drug Nebulizer MK III (K860875) received a 510(k) decision of Substantially Equivalent on March 20, 1986, 23 days after the submission was received.
What is the product code of K860875?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.