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

    3B RESMART BPAP 25A, BMC RESMART BPAP 25A

    K Number: K133769 · Decision Aug 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    449
    Applicant Total
    5
    Review Days
    257

    Basic Information

    Device Name
    3B RESMART BPAP 25A, BMC RESMART BPAP 25A
    K Number
    K133769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3B MEDICAL, INC
    Date Received
    December 11, 2013
    Decision Date
    August 25, 2014
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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