BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    MEGA AMNIOCENTESIS KIT

    K Number: K915863 · Decision Mar 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    90

    Basic Information

    Device Name
    MEGA AMNIOCENTESIS KIT
    K Number
    K915863
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    MEGA MEDICAL, INC.
    Date Received
    December 31, 1991
    Decision Date
    March 30, 1992
    Product Code
    HIO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

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    Other Clearances by MEGA MEDICAL, INC.

    K Number Device Name
    K913397 MEGA ANGIOGRAM KIT
    K913317 MEGA ARTHROGRAM KIT
    K912445 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
    K913382 MEGA PARACENTESIS KIT
    K912322 MEGA SPINAL ANESTHESIA KIT
    K912564 MEGA PERICARDIOCENTESIS KIT