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The Julian is indicated as a continuous flow anesthesia system. The Julian may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume.

The Julian is a continuous flow gas anesthesia system.

The provided text does not contain information on acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) premarket notification letter from the FDA regarding the Julian Anesthesia Workstation.

The document discusses:

• Manufacturer and device details: Dräger Medientechnik GmbH, Julian Anesthesia Workstation, Class II device.
• Intended Use: Continuous flow gas anesthesia system for spontaneous, manually assisted, or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of various parameters (oxygen, breathing pressure, respiratory volume, CO2, N2O, anesthetic agent).
• Substantial Equivalence: Comparison to predicate devices (Narkomed 6000 Anesthesia System, Divan, Evita 2 Dura, Combination Oximeter/Carbon Dioxide Gas Analyzer) in terms of features, functions, and design elements.
• Testing: Mentions "hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing" as part of the qualification.
• FDA Acknowledgment: The letter from the FDA approving the device for marketing based on substantial equivalence.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details because this information is not present in the given text.

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