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

    UNIVERSAL SUCTION PUMP TYPE EUS

    K Number: K813312 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    10
    Review Days
    37

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    Basic Information

    Device Name
    UNIVERSAL SUCTION PUMP TYPE EUS
    K Number
    K813312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Egnell, Inc.
    Date Received
    November 24, 1981
    Decision Date
    December 31, 1981
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Egnell, Inc.

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