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

    ABDOMINAL ECG PROCESSOR FOR FETAL MONI.

    K Number: K770295 · Decision Mar 9, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
    K Number
    K770295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Brattle Instrument Corp.
    Date Received
    February 14, 1977
    Decision Date
    March 9, 1977
    Product Code
    HGI
    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
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Brattle Instrument Corp.

    K Number Device Name
    K810588 SYNCHRONIZER #208
    K802978 TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
    K781681 PHIPIOLOGICAL SYNCHRONIZER PART#205
    K770692 MONITOR, FETAL, NO. L04-1100
    K770296 FETAL MONITOR, PART #101-11009
    K770297 FETAL MONITOR, PART #100-11009