Ergofilter Spi Accessory to Spirolyser SPL-50
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by FIM Medical
Identifiers
- 510(k) Number
- K050424 FDA 510(k)
- FDA Product Code
- BZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1840 FDA 510(k)
- Regulation Number
- 868.1840 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ergofilter Spi Accessory to Spirolyser SPL-50 is a spirometer accessory designed for use with respiratory diagnostic equipment. It functions as a filter component to improve the accuracy and reliability of spirometry measurements by reducing contamination and ensuring clean airflow during pulmonary function testing.
This accessory is supplied as a reusable component intended for use in clinical settings such as hospitals, pulmonary function labs, or anesthesia departments. It is not sterile and requires cleaning and maintenance between uses. The device is classified as a Class II medical device under FDA regulations (21 CFR 868.1840) and has received FDA 510(k) clearance and MDD authorization. Compatibility is specific to the Spirolyser SPL-50 system.
Frequently asked questions
What is the primary purpose of the Ergofilter Spi Accessory for the Spirolyser SPL-50?
The Ergofilter Spi Accessory is designed to enhance the accuracy and reliability of spirometry measurements by filtering airflow during pulmonary function tests. It reduces contamination, ensuring cleaner airflow for more precise diagnostic results in clinical settings like hospitals or pulmonary labs.
Is the Ergofilter Spi Accessory sterile, and how should it be maintained between uses?
The Ergofilter Spi Accessory is not sterile and is intended for reusable clinical use. It requires proper cleaning and maintenance between uses to prevent contamination and ensure optimal performance. Follow manufacturer guidelines for disinfection protocols to maintain hygiene and functionality.
What types of clinical environments is this accessory compatible with, and what system does it pair with?
The Ergofilter Spi Accessory is designed for use in clinical settings such as hospitals, pulmonary function labs, and anesthesia departments. It is exclusively compatible with the Spirolyser SPL-50 system, meaning it will not function with other spirometry devices.
What regulatory approvals does the Ergofilter Spi Accessory hold, and how does it classify under FDA regulations?
The Ergofilter Spi Accessory holds FDA 510(k) clearance and MDD authorization, confirming its compliance with regulatory standards. Under FDA regulations, it is classified as a Class II medical device (21 CFR 868.1840), indicating moderate regulatory oversight due to its role in improving diagnostic accuracy for respiratory testing.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K050424 | Class II | Active |
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Manufacturer
- Manufacturer
- FIM Medical
Sources (2)
- FDA 510(k) K050424 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026