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

    EGNELL-LACT B BATTERY-OPERATED BREAST PUMP

    K Number: K844307 · Decision Feb 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    10
    Review Days
    98

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    Basic Information

    Device Name
    EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
    K Number
    K844307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Egnell, Inc.
    Date Received
    October 29, 1984
    Decision Date
    February 4, 1985
    Product Code
    HGX
    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
    HGX Pump, Breast, Powered

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    Other Clearances by Egnell, Inc.

    K Number Device Name
    K853909 EGNELL UNIVERSAL SUCTION PUMP
    K853917 EGNELL COMPACT SUCTION PUMP
    K840526 AMETHERM
    K834335 AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
    K832637 AMEDA NEONATAL RESUSCITATION UNIT-
    K813312 UNIVERSAL SUCTION PUMP TYPE EUS
    K813095 GASTRIC JUICES SUCTION PUMP
    K812898 PE-01 ELECTRONIC INFUSION PUMP
    K812020 EGNELL COMPACT, TYPE EHV