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

    MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307

    K Number: K060739 · Decision Jul 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    123

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    Basic Information

    Device Name
    MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
    K Number
    K060739
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Khrunichev State Research & Production Space Centr
    Date Received
    March 20, 2006
    Decision Date
    July 21, 2006
    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 Khrunichev State Research & Production Space Centr

    K Number Device Name
    K011312 BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM