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510(k) Data Aggregation

    K Number
    K991363

    Validate with FDA (Live)

    Device Name
    30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
    Manufacturer
    SORENSON MEDICAL, INC.
    Date Cleared
    1999-05-13

    (23 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K941595,K965222
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information required to fulfill your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (pumps for fluid and medication infusion). It confirms substantial equivalence but does not include details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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