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The Compat GOTM feeding pump with the administration sets are intended exclusively for enteral feeding. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system. Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.

The Compat GOTM Enteral Feeding Pump ( a Class II device) and Enteral Administration Sets are designed to deliver formulas and Enteral hydration liquids via linear peristaltic pumping to provide nutrition for patients which are not able to ingest food orally. The Compat GOTM Enteral Feeding_System is working with the Compat GO™ Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets only caused by its adapted safety and effectiveness concept. The Compat GOTM Enteral Administration Sets are compatible with the standard prefilled formula containers presently available on the market. The Compat GO™ Enteral Administration Sets are designed to compatible with present market Enteral access devices and accessories.

The provided text is a 510(k) Premarket Notification for the Fresenius Applix Smart/Compat GO enteral feeding pump and administration sets. It does not contain information about studies proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, outlining the device description, intended use, and product comparison to predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical study report.

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