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

    BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER

    K Number: K962103 · Decision Aug 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    45
    Review Days
    84

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    Basic Information

    Device Name
    BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
    K Number
    K962103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    May 30, 1996
    Decision Date
    August 22, 1996
    Product Code
    MNR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNR Ventilatory Effort Recorder

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