BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    S-41 & S-41S VIDEO IMAGING SYSTEM

    K Number: K962020 · Decision Aug 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    99

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    Basic Information

    Device Name
    S-41 & S-41S VIDEO IMAGING SYSTEM
    K Number
    K962020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Del Medical Systems Corp.
    Date Received
    May 23, 1996
    Decision Date
    August 30, 1996
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Del Medical Systems Corp.

    K Number Device Name
    K962684 S-357 VIDEO IMAGING SYSTEM
    K960301 ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
    K962651 S-52 ELECTRONIC VIDEO LAPAROSCOPE
    K962979 S-53 INTRORAL DENTAL SYSTEM
    K962024 S-57 VIDEO IMAGING SYSTEM
    K942924 MSV-2000 VIDEO IMAGING SYSTEM