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The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.

The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Bestneb Portable Aerosol Therapy Unit, AP-10010". As such, it does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as typically found in clinical trial reports or detailed scientific publications.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the device was cleared based on its equivalence to a legally marketed predicate device, not necessarily on a novel study demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The document primarily confirms regulatory clearance based on substantial equivalence.

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