Iqteq Development
ZA Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Iqteq Spirometer Ref K020102
What Iqteq Development makes
Iqteq Development manufactures the IQTEQ Spirometer, a diagnostic device used to measure lung function by assessing airflow and lung volume. It is designed for clinical and home use to evaluate respiratory conditions such as asthma, COPD, and other pulmonary disorders.
The IQTEQ Spirometer is classified as a Class II medical device under FDA regulations and is authorised through the 510(k) clearance process. The company is based in the United States.
Frequently asked questions
What types of medical devices does Iqteq Development manufacture?
Iqteq Development specializes in diagnostic devices, specifically the IQTEQ Spirometer. This device measures lung function by evaluating airflow and lung volume, helping assess respiratory conditions like asthma, COPD, and other pulmonary disorders. It is designed for both clinical and home use.
Where is Iqteq Development based?
Iqteq Development is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
How are the devices manufactured by Iqteq Development classified under regulatory standards?
The IQTEQ Spirometer, the primary device produced by Iqteq Development, is classified as a Class II medical device under FDA regulations. This classification typically applies to devices with moderate risk, requiring special controls to ensure safety and effectiveness. The classification influences the regulatory pathway, such as the 510(k) clearance process, which demonstrates that the device is substantially equivalent to a legally marketed predicate device.
Which regulatory registries or databases list devices from Iqteq Development?
The IQTEQ Spirometer is listed in the FDA’s 510(k) database, which tracks devices that have undergone the 510(k) clearance process. This registry confirms that the device has met FDA requirements for safety and performance before being authorised for market distribution in the U.S. Other registries or databases may also include it depending on broader compliance tracking systems.
Information
- Country
- ZA