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510(k) Data Aggregation

    K Number
    K163424
    Device Name
    AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
    Manufacturer
    United State Endoscopy Group, Inc.
    Date Cleared
    2017-01-04

    (29 days)

    Product Code
    FEQ, FEO
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    United State Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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