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

    THERMOTHERAPY

    K Number: K822217 · Decision Sep 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    17
    Review Days
    60

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    Basic Information

    Device Name
    THERMOTHERAPY
    K Number
    K822217
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Luther Medical Products, Inc.
    Date Received
    July 26, 1982
    Decision Date
    September 24, 1982
    Product Code
    LKX
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKX Device, Thermal, Hemorrhoids

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    K974543 L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
    K940198 L-CATH CONNECTOR ASSEMBLY
    K942103 L-CATH CATHETER SYSTEM - PORT L-CATH
    K930473 ONECATH L-CATH CATHETER SYSTEM
    K925236 L CATH(R) CATHETER SYSTEM
    K920755 L-CATH PEEL AWAY SYSTEM CATHETER
    K925979 DUAL LUMEN L-CATH CATHETER SYSTEM
    K924968 L-CATH PEEL-AWAY CATHETER SYSTEM
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