Cirrus Nebulizer-Deluxe Kit
FDA 510(k) K854952 · Dhd Medical Products Div. Diemolding Corp.
510(k) numberK854952
Submission
- Device name
- Cirrus Nebulizer-Deluxe Kit
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
Canastota, NY, US - Received
- December 10, 1985
- Decision date
- January 28, 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
Other 510(k)s with product code CCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| 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 Nebulizer-Deluxe Kit cleared by the FDA?
Cirrus Nebulizer-Deluxe Kit (K854952) received a 510(k) decision of Substantially Equivalent on January 28, 1986, 49 days after the submission was received.
What is the product code of K854952?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.