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

    SleepImage System

    K Number: K163696 · Decision Oct 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    2
    Review Days
    288

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    Basic Information

    Device Name
    SleepImage System
    K Number
    K163696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mycardio, LLC Dba Sleepimage.
    Date Received
    December 29, 2016
    Decision Date
    October 13, 2017
    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 Mycardio, LLC Dba Sleepimage.

    K Number Device Name
    K182618 SleepImage System