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

    QUANTITATIVE SENTINEL SYSTEM

    K Number: K960109 · Decision Aug 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    8
    Review Days
    203

    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
    QUANTITATIVE SENTINEL SYSTEM
    K Number
    K960109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantitative Medicine, Inc.
    Date Received
    January 11, 1996
    Decision Date
    August 1, 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 Quantitative Medicine, Inc.

    K Number Device Name
    K963608 QUANTITATIVE SENTINEL SYSTEM
    K923255 Q-SD
    K912462 Q-MS NEUROMUSCULAR STIMULATOR
    K912460 Q-TENS
    K912463 MICRO-Q
    K904603 QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
    K833395 SENTINEL SYSTEMS