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

    MODEL 1888 ALPHA COS/RESPIRATION CAR

    K Number: K834460 · Decision Feb 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    46
    Review Days
    56

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    Basic Information

    Device Name
    MODEL 1888 ALPHA COS/RESPIRATION CAR
    K Number
    K834460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Spacelabs, Inc.
    Date Received
    December 19, 1983
    Decision Date
    February 13, 1984
    Product Code
    LLK
    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
    LLK Legging, Compression, Non-Inflatable

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