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The antistatic Compact Space Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.

Antistatic Compact Space Chamber

The provided document is a 510(k) premarket notification letter from the FDA regarding an "Antistatic Compact Space Chamber" (K143615), which is a nebulizer. It indicates the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria for device performance, outcomes from a study proving it meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

The letter is a regulatory approval document and focuses on the administrative aspects of FDA clearance, such as:

• Trade/Device Name: Antistatic Compact Space Chamber
• Regulation Number/Name: 21 CFR 868.5630, Nebulizer
• Regulatory Class: Class II
• Product Code: NVP
• Indications for Use: Administer aerosolized medication from most pressurized Metered Dose Inhalers to neonates, infants, children, adolescents, and adults in home, hospitals, and clinics.

To answer your request, information regarding the device's technical performance and the studies demonstrating it would need to be found in the original 510(k) submission itself or in relevant performance data documents, which are not included in this provided text.

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