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510(k) Data Aggregation

    K Number
    K962684
    Device Name
    S-357 VIDEO IMAGING SYSTEM
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-10-15

    (97 days)

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

    DEL MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
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    K Number
    K960301
    Device Name
    ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-09-30

    (252 days)

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

    DEL MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical Adaptive Image Processor for Medical Applications
    Device Description
    The design of the nD Vision-220, Medical Adaptive Image Processor for Medical Applications is virtually identical to the comparative device manufactured and sold by Digivision.
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    K Number
    K962651
    Device Name
    S-52 ELECTRONIC VIDEO LAPAROSCOPE
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-09-30

    (84 days)

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

    DEL MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The S-52 Electronic Video Laparossope
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    K Number
    K962979
    Device Name
    S-53 INTRORAL DENTAL SYSTEM
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-09-25

    (56 days)

    Product Code
    DZA
    Regulation Number
    872.4130
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the intended use the same
    Device Description
    The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3.
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    K Number
    K962020
    Device Name
    S-41 & S-41S VIDEO IMAGING SYSTEM
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-08-30

    (99 days)

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

    DEL MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the intended use the same
    Device Description
    The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3.
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    K Number
    K962024
    Device Name
    S-57 VIDEO IMAGING SYSTEM
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-07-09

    (47 days)

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

    DEL MEDICAL SYSTEMS CORP.

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

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