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

    EP-100 INFUSION PUMP

    K Number: K883653 · Decision Nov 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    5
    Review Days
    67

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    Basic Information

    Device Name
    EP-100 INFUSION PUMP
    K Number
    K883653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Stereotactic Medical Systems, Inc.
    Date Received
    August 26, 1988
    Decision Date
    November 1, 1988
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Stereotactic Medical Systems, Inc.

    K Number Device Name
    K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    K884415 EP-100 (SERIES)
    K871046 COMPASS STEREOTACTIC POSITIONING SYSTEM
    K862220 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM