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510(k) Data Aggregation

    K Number
    K001742
    Device Name
    RESUSCI INFLATE-A-SHIELD CPR BARRIER
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    2000-10-06

    (120 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962361
    Device Name
    TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    1996-09-05

    (78 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954771
    Device Name
    TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    1996-05-09

    (205 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.
    Device Description
    The Trachlight includes a wand with an incandescent light bulb at its tip that is placed inside the endotracheal tube prior to intubation, with the light bulb positioned at the end of the endotracheal tube. Light from the light bulb helps provide a guide for the clinician during the intubation process, and light emanating from the light bulb can be seen through the patient's tissue when the end of the endotracheal tube is properly positioned in the patient's trachea. The Trachlight consists of a reusable handle that contains the batteries and electronic circuits to apply power to the light bulb; a sterile, flexible wand that contains the light bulb at the tip; and a stylet that slides into the wand and acts as a stiffening member when needed.
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    K Number
    K954609
    Device Name
    HEARTSTART 911
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    1996-01-04

    (92 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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