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

    PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.

    K Number: K873150 · Decision Mar 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    213

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    Basic Information

    Device Name
    PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
    K Number
    K873150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pediatric Diagnostic Service
    Date Received
    August 11, 1987
    Decision Date
    March 11, 1988
    Product Code
    HFM
    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
    HFM Monitor, Uterine Contraction, External (For Use In Clinic)

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    Other Clearances by Pediatric Diagnostic Service

    K Number Device Name
    K882084 GENESIS TM FETAL SYSTEM