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

    Rubicon SA System

    K Number: K200654 · Decision Jul 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    2
    Review Days
    132

    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
    Rubicon SA System
    K Number
    K200654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dymedix Diagnostics, Inc.
    Date Received
    March 12, 2020
    Decision Date
    July 22, 2020
    Product Code
    MNR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNR Ventilatory Effort Recorder

    Similar 510(k) Clearances

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

    CASSIE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SANSA HSAT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SANSA HSAT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WatchPAT400 (WP400)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Somfit D

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Onera STS 2 (ONERA STS 2)

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

    Other Clearances by Dymedix Diagnostics, Inc.

    K Number Device Name
    K192564 Disposable Gold Cup EEG Electrodes