Inspiron Nebulo 28 Nebulizer Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K790982 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inspiron Nebulo 28 Nebulizer Kit is a medical device classified as a nebulizer, designed to administer aerosolized medication directly to the respiratory tract. It converts liquid medication into a fine mist for inhalation, facilitating treatment of respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disorders. The device operates by passing compressed air or oxygen through a liquid medication reservoir, dispersing it into small particles for effective delivery.
This kit is supplied as a single-use device and requires no sterilization between uses. It is intended for use in clinical settings, including hospitals, outpatient clinics, and home care environments. The Inspiron Nebulo 28 Nebulizer Kit holds an FDA 510(k) clearance (K790982) under the Anesthesiology advisory committee, classified under product code CAF. No MRI safety information or reusable components are specified in the regulatory data.
Frequently asked questions
What is the Inspiron Nebulo 28 Nebulizer Kit used for?
The Inspiron Nebulo 28 Nebulizer Kit is designed to administer aerosolized medication directly to the respiratory tract. It converts liquid medication into a fine mist for inhalation, making it ideal for treating respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disorders. The device works by dispersing medication into small particles using compressed air or oxygen, ensuring effective delivery to the lungs.
Is the Inspiron Nebulo 28 Nebulizer Kit single-use or reusable?
The Inspiron Nebulo 28 Nebulizer Kit is explicitly supplied as a single-use device. This design eliminates the need for sterilization between uses, reducing the risk of cross-contamination and simplifying clinical workflows. It is intended for one-time use per patient session, ensuring hygiene and reliability in both hospital and home care environments.
Where can the Inspiron Nebulo 28 Nebulizer Kit be used?
This nebulizer kit is approved for use in clinical settings, including hospitals, outpatient clinics, and home care environments. Its single-use nature makes it particularly suitable for environments where infection control is critical, such as patient rooms or home respiratory therapy setups. The device’s design ensures ease of use across diverse healthcare settings.
Does the Inspiron Nebulo 28 Nebulizer Kit require sterilization?
No, the Inspiron Nebulo 28 Nebulizer Kit does not require sterilization between uses. As a single-use device, it is intended for one-time use per patient, which inherently reduces the risk of contamination. This feature streamlines clinical procedures and minimizes the need for additional processing steps.
What regulatory clearance does the Inspiron Nebulo 28 Nebulizer Kit hold?
The Inspiron Nebulo 28 Nebulizer Kit holds FDA 510(k) clearance under the Anesthesiology advisory committee, with clearance number K790982. This classification under product code CAF confirms its compliance with U.S. regulatory standards for medical devices intended for respiratory therapy. The clearance reflects its substantial equivalence to previously marketed devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INSPIRON NEBULO TM 28 NEBULIZER KIT - fda.innolitics.com, K790982 FDA 510(k) - INSPIRON NEBULO TM 28 NEBULIZER KIT, PDF K790982 - Inspiron Nebulo Tm 28 Nebulizer Kit, INSPIRON NEBULO TM 28… — K790982 · DeviceClearance, Nebulo 28 Nebulizer Kit - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K790982 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K790982 24 fields · synced Oct 1, 2026