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

    ALPHA-I

    K Number: K832642 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    109

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    Basic Information

    Device Name
    ALPHA-I
    K Number
    K832642
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Johnson Flexgroup
    Date Received
    August 4, 1983
    Decision Date
    November 21, 1983
    Product Code
    LHC
    Advisory Committee
    Physical Medicine
    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
    LHC Warmer, Irrigation Solution

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