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This product is a hand held nebulizer that is used to provide aerosolized broncho dialator medication to persons with asthma or emphysema. The device creates aerosolized particles of the prescribed medication via interface with a nebulizer compressor.

This product is a hand held nebulizer. The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles. The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "BRENEB HAND HELD NEBULIZER." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Instead, it's a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices. This means the manufacturer demonstrated that their device performs similarly to existing, approved devices, rather than presenting a study against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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