BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    Ambu USR, Ambu M

    K Number: K160766 · Decision Aug 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    79
    Applicant Total
    15
    Review Days
    149

    Basic Information

    Device Name
    Ambu USR, Ambu M
    K Number
    K160766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMBU A/S
    Date Received
    March 21, 2016
    Decision Date
    August 17, 2016
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by AMBU A/S

    K Number Device Name
    K161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
    K152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
    K130845 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
    K110962 AMBU ASCOPE 2
    K102824 AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
    K100129 AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
    K093186 AMBU ASCOPE AND MONITOR
    K093825 AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
    K071186 MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
    K071185 MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
    Search all 15 clearances from AMBU A/S →