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

    AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER

    K Number: K131786 · Decision Jul 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    10
    Review Days
    15

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    Basic Information

    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
    K Number
    K131786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Airstrip Technologies, LP
    Date Received
    June 18, 2013
    Decision Date
    July 3, 2013
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Airstrip Technologies, LP

    K Number Device Name
    K133450 AIRSTRIP REMOTE PATIENT MONITORING
    K133394 AIRSTRIP REMOTE PATIENT MONITORING
    K122133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K121871 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K112235 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    K110503 AIRSTRIP REMOTE PATIENT MONITORING (RPM)
    K100133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
    K090269 AIRSTRIP OB
    K090061 AIRSTRIP OB