Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K982884
    Device Name
    DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH
    Manufacturer
    NEW DEANTRONICS, LTD.
    Date Cleared
    1998-09-14

    (28 days)

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

    NEW DEANTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Device Description
    New Deantronics, Inc. Model SB 312 Disposable Hand Switching Pencil, Rocker Switch, two piece.
    Ask a Question
    K Number
    K982130
    Device Name
    RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
    Manufacturer
    NEW DEANTRONICS, LTD.
    Date Cleared
    1998-08-07

    (51 days)

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

    NEW DEANTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgery accessory. Patient return electrode conductor cable for use with the Valleylab E7509 and similar return electrode monitor compatible patient return electrodes that do not have integral cords.
    Device Description
    Return Electrode Clamp Shell Cord
    Ask a Question

    Page 1 of 1