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

    SMARTMONITOR 2PS

    K Number: K061256 · Decision Aug 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    172
    Review Days
    90

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    Basic Information

    Device Name
    SMARTMONITOR 2PS
    K Number
    K061256
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Respironics, Inc.
    Date Received
    May 4, 2006
    Decision Date
    August 2, 2006
    Product Code
    NPF
    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
    NPF Monitor, Apnea, Home Use

    Similar 510(k) Clearances

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    SMARTMONITOR 2 PROFESSIONAL SERIES (PS)

    FDA 510(k)
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