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K Number
K983635
Device Name
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
1999-01-11

(88 days)

Product Code
BSZ
Regulation Number
868.5160
Type
Traditional
Panel
AN
Reference & Predicate Devices
K980553,K980280,K970165,K964239
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

The Julian is a continuous flow gas anesthesia system.

AI/ML Overview

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.

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).