BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SONOTT FLOWLAB(R)

    K Number: K111730 · Decision Jan 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    200

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SONOTT FLOWLAB(R)
    K Number
    K111730
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Em-Tec GmbH
    Date Received
    June 20, 2011
    Decision Date
    January 6, 2012
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.

    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Elfor-L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Em-Tec GmbH

    K Number Device Name
    K080704 LOW FLUID ALARM
    K040909 SONO TT ULTRASONIC FLOWCOMPUTER