BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINI TELEMETRY SYSTEM

    K Number: K110556 · Decision Jul 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    5
    Review Days
    141

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MINI TELEMETRY SYSTEM
    K Number
    K110556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wipro GE Healthcare Private, Ltd.
    Date Received
    February 28, 2011
    Decision Date
    July 19, 2011
    Product Code
    HGM
    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
    HGM System, Monitoring, Perinatal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HGM), ordered by most recent decision date.

    ANNE Maternal

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonicaid Team3

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fetal & Maternal Monitor (F15A, F15A Air)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonicaid Team3

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PeriCALM Patterns 3.0

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Wipro GE Healthcare Private, Ltd.

    K Number Device Name
    K123681 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
    K121625 LULLABY TM WARMER
    K120168 LULLABY LED PHOTTHERAPY SYSTEM
    K102104 GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM