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510(k) Data Aggregation
(142 days)
ENTERAL PUMP SET, MODEL 20-1010
The Enteral Pump Set is intended to dispense liquid nutrients from enteral formula containers with SpikeRight™ port via VIASYS MedSystems Enteral Pumps.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Enteral Pump Set Model 20-1010AIV." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the provided document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications. The document is solely a regulatory approval letter and an indications for use statement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as this information is not present in the provided text.
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