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

    CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV

    K Number: K991195 · Decision Apr 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    14
    Review Days
    14

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    Basic Information

    Device Name
    CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
    K Number
    K991195
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O-Two Systems Intl., Inc.
    Date Received
    April 8, 1999
    Decision Date
    April 22, 1999
    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 Systems Intl., Inc.

    K Number Device Name
    K983857 AUTOVENT 1500
    K983785 AUTOVENT 1000
    K983643 GENESIS BLS
    K983705 EMT RESUSCITATOR
    K960995 CPR BIO-BARRIER FACESHEILD
    K940712 PPM III
    K940927 RESCUE BREATHER
    K932170 FLYNNR GENESIS II A/C, A/O AND IDLH
    K922810 ODYSSEY
    K913039 FLLYNN(R) GENESIS AC
    Search all 14 clearances from O-Two Systems Intl., Inc. →