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

    MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)

    K Number: K955931 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    10
    Review Days
    243

    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
    MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
    K Number
    K955931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Advanced Medical Systems, Inc.
    Date Received
    December 15, 1995
    Decision Date
    August 14, 1996
    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 Advanced Medical Systems, Inc.

    K Number Device Name
    K952031 ULTRASOUND TRANSDUCER, MODEL US917
    K940898 MODEL IM77 INTRAPARTUM FETAL MONITOR
    K923335 ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
    K932278 PFM PROFESSIONAL 7000 SPIROMETER
    K911657 FETAL SCALP SPIRAL ELECTRODE
    K902190 FETAL PULSE DETECTOR MODEL DOP-1
    K894568 NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
    K891672 PUL-TRON 100K PROFESSIONAL SPIROMETER
    K880756 MODEL PM-20A PHYSIOLOGICAL MONITOR