Microcirrus Medical Nebulizer
FDA 510(k) K881935 · Dhd Medical Products Div. Diemolding Corp.
510(k) numberK881935
Submission
- Device name
- Microcirrus Medical Nebulizer
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
Canastota, NY, US - Received
- May 9, 1988
- Decision date
- June 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| K860878 | British Breathing Circuit SystemBZA · Traditional | 03/20/1986SE |
Questions and answers
When was Microcirrus Medical Nebulizer cleared by the FDA?
Microcirrus Medical Nebulizer (K881935) received a 510(k) decision of Substantially Equivalent on June 22, 1988, 44 days after the submission was received.
What is the product code of K881935?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.