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

    SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH

    K Number: K014299 · Decision Jan 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    113
    Applicant Total
    4
    Review Days
    30

    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
    SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
    K Number
    K014299
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sorba Medical Systems, Inc.
    Date Received
    December 31, 2001
    Decision Date
    January 30, 2002
    Product Code
    DSB
    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
    DSB Plethysmograph, Impedance

    Similar 510(k) Clearances

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

    BCM2-Body Composition Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Re:Balans

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edema Guard Monitor (EGM) CardioSet-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOZO Pro

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zynex Monitoring System, Model CM-1600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bodyport Cardiac Scale

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

    Other Clearances by Sorba Medical Systems, Inc.

    K Number Device Name
    K950389 SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
    K901926 SORBA MODEL CIC-1000 W/NEW ELECTRODES
    K895017 SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH