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

    AIRSTRIP OB

    K Number: K090269 · Decision Feb 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    10
    Review Days
    10

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    Basic Information

    Device Name
    AIRSTRIP OB
    K Number
    K090269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Airstrip Technologies, LP
    Date Received
    February 3, 2009
    Decision Date
    February 13, 2009
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    Other Clearances by Airstrip Technologies, LP

    K Number Device Name
    K133450 AIRSTRIP REMOTE PATIENT MONITORING
    K133394 AIRSTRIP REMOTE PATIENT MONITORING
    K131786 AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
    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
    K090061 AIRSTRIP OB