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

    AIRHYTHM HEALTHCARE BED

    K Number: K935837 · Decision Jun 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    196

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    Basic Information

    Device Name
    AIRHYTHM HEALTHCARE BED
    K Number
    K935837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthcare Designs
    Date Received
    December 7, 1993
    Decision Date
    June 21, 1994
    Product Code
    FNL
    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
    FNL Bed, Ac-Powered Adjustable Hospital

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