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

    INFINITY PICCO POD, MODEL MS16734

    K Number: K073113 · Decision Jan 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    48
    Review Days
    59

    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
    INFINITY PICCO POD, MODEL MS16734
    K Number
    K073113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Systems, Inc.
    Date Received
    November 5, 2007
    Decision Date
    January 3, 2008
    Product Code
    DXG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

    Similar 510(k) Clearances

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

    Argos Infinity (Rev. 1.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalStream ART Connect; VitalStream-Hemo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hypotension Decision Assist Model HDA-OR2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PulsioFlex Monitoring System with ProAQT Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EV1000 Clinical Platform

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

    Other Clearances by Draeger Medical Systems, Inc.

    K Number Device Name
    K243606 Babyroo TN300
    K240312 Infinity CentralStation Wide
    K233834 Infinity Gateway Suite
    K231477 Infinity CentralStation Wide, Infinity M300, Infinity M300+
    K230278 Babyroo TN300
    K203579 Infinity Gateway Suite
    K203088 Infinity Acute Care System (IACS) Monitoring System
    K201764 Infinity Acute Care System (IACS) Monitoring Solution
    K200859 Infinity M300
    K182977 Isolette 8000 Plus
    Search all 48 clearances from Draeger Medical Systems, Inc. →