LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990962
    Device Name
    FLOSENSE, MODEL 29-8010
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2000-01-07

    (291 days)

    Product Code
    JAX
    Regulation Number
    868.2550
    Why did this record match?
    Product Code :

    JAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1