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

    SLEEP PAT 200 DEVICE

    K Number: K010156 · Decision Jun 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    3
    Review Days
    519

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    Basic Information

    Device Name
    SLEEP PAT 200 DEVICE
    K Number
    K010156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Itamar Medical (C.M.) 1997 , Ltd.
    Date Received
    January 16, 2001
    Decision Date
    June 19, 2002
    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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    Other Clearances by Itamar Medical (C.M.) 1997 , Ltd.

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