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

    O-TWO E700,O-TWO E600,O-TWO E500

    K Number: K141595 · Decision Mar 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    8
    Review Days
    276

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    Basic Information

    Device Name
    O-TWO E700,O-TWO E600,O-TWO E500
    K Number
    K141595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O-Two Medical Technologies, Inc.
    Date Received
    June 13, 2014
    Decision Date
    March 16, 2015
    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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    Other Clearances by O-Two Medical Technologies, Inc.

    K Number Device Name
    K173205 Equinox Advantage
    K113687 EQUINOX RELIEVE
    K112546 O_TWO CPAP SYSTEM
    K093862 CAREVENT HANDHELD CPAP SYSTEM
    K081330 CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
    K051469 CAREVENT ATV+ AND CAREVENT MRI
    K051889 CAREVENT CA AND DRA