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

    SAPCRILL THERMODETECT BREAST SCANNER DEV

    K Number: K801573 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    SAPCRILL THERMODETECT BREAST SCANNER DEV
    K Number
    K801573
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    California Cardiac Systems, Inc.
    Date Received
    July 9, 1980
    Decision Date
    September 9, 1980
    Product Code
    KYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KYZ Syringe, Irrigating (Non Dental)

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