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    K Number
    K170105
    Device Name
    Jac-Cell Medic testers
    Manufacturer
    JAC-CELL MEDIC
    Date Cleared
    2017-02-28

    (47 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAC-CELL MEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.
    Device Description
    The tester is a non-sterile multiple use handheld device operated by 9V battery. An embedded software (firmware) is used to program a microcontroller hardware platform, that interface the user's actions with visual and audible output signals. The tester is used pre-operating room by nurses in hospitals, for the purpose of verifying the insulation (for ATI-021 and ATI-014A) and continuity (for ATI-014A) of electrosurgical instruments. The tester is tested for functionality prior to each use.
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    K Number
    K020334
    Device Name
    INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC
    Manufacturer
    JAC-CELL MEDIC CORPORATION
    Date Cleared
    2002-10-03

    (245 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAC-CELL MEDIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ATI-014 Insulation and Continuity Testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments.
    Device Description
    The ATI 014FC Insulation and Continuity Tester and InsulScan Insulation Testing System have the same indications for use, basic design, both are battery operated battery operated and rechargeable.
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