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

    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1

    K Number: K021690 · Decision Oct 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    4
    Review Days
    155

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    Basic Information

    Device Name
    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
    K Number
    K021690
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pan-America Hyperbarics, Inc.
    Date Received
    May 22, 2002
    Decision Date
    October 24, 2002
    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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    Other Clearances by Pan-America Hyperbarics, Inc.

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    K122560 VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
    K021689 PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
    K021693 PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1