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This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.

This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.

The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.

The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "Master Neb II" from 1997. It describes the device's intended use and states its substantial equivalence to previously marketed devices. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any information related to AI or MRMC studies.

Therefore, I cannot extract any of the requested information to fill in the table or answer the specific questions about device performance and studies.

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