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510(k) Data Aggregation

    K Number
    K122040
    Device Name
    INVOTEC LARYNGEAL ELECTRODE
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    2013-10-31

    (476 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.
    Device Description
    Not Found
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    K Number
    K080740
    Device Name
    CLEARVIEW ENDOSCOPE COVER
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    2008-12-31

    (289 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.
    Device Description
    Flexible Endoscope Barrier Sheath.
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    K Number
    K030492
    Device Name
    TITANIUM OSSICULAR REPLACMENT SYSTEM
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    2003-03-03

    (12 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.
    Device Description
    Titanium Ossicular Replacement System
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    K Number
    K973580
    Device Name
    INVOTEC CLEAN PAD
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    1997-12-10

    (82 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.
    Device Description
    Not Found
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    K Number
    K973578
    Device Name
    INVOTEC EAR TAMPON (WICK) W/STRING
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    1997-11-06

    (48 days)

    Product Code
    KCN
    Regulation Number
    874.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.
    Device Description
    Invotec Ear Tampon (Wick) w/String
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    K Number
    K971000
    Device Name
    EPISTAXIS NASAL PACK
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    1997-05-14

    (56 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVOTEC INTERNATIONAL, INC.

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