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510(k) Data Aggregation
(147 days)
EMG HANDLE NEBULIZER NB02 SERIES
The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.
The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.
The provided text is a 510(k) premarket notification letter from the FDA regarding a nebulizer. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.
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