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

    H.A.M. APPLICATOR

    K Number: K961601 · Decision Dec 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    43
    Review Days
    242

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    Basic Information

    Device Name
    H.A.M. APPLICATOR
    K Number
    K961601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mick Radio-Nuclear Instruments, Inc.
    Date Received
    April 25, 1996
    Decision Date
    December 23, 1996
    Product Code
    JAQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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    K122840 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
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    K052351 HDR IORT SHIELDED APPLICATOR
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    K040704 MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
    Search all 43 clearances from Mick Radio-Nuclear Instruments, Inc. →