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

    OxyHeal 4000 Multiplace Hyperbaric Chamber Family

    K Number: K163109 · Decision Mar 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    135

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    Basic Information

    Device Name
    OxyHeal 4000 Multiplace Hyperbaric Chamber Family
    K Number
    K163109
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxyheal Medical Systems, Inc.
    Date Received
    November 7, 2016
    Decision Date
    March 22, 2017
    Product Code
    CBF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CBF Chamber, Hyperbaric

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