BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL MC-1 SURGICAL VIDEO CAMERA

    K Number: K863376 · Decision Oct 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    MODEL MC-1 SURGICAL VIDEO CAMERA
    K Number
    K863376
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biometric Products, Inc.
    Date Received
    September 3, 1986
    Decision Date
    October 2, 1986
    Product Code
    FWF
    Advisory Committee
    General, Plastic Surgery
    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
    FWF Camera, Television, Endoscopic, Without Audio

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    Other Clearances by Biometric Products, Inc.

    K Number Device Name
    K933021 MODEL T131 MEMORY TRANSMITTER
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    K840032 TELEPHONE RECEIVERS R101 R111
    K832951 MEMORY LOOP TRANSMITTER #121