BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FLYNNR GENESIS II A/C, A/O AND IDLH

    K Number: K932170 · Decision Oct 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    14
    Review Days
    174

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    Basic Information

    Device Name
    FLYNNR GENESIS II A/C, A/O AND IDLH
    K Number
    K932170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O-Two Systems Intl., Inc.
    Date Received
    May 4, 1993
    Decision Date
    October 25, 1993
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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