BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SPECTRUM M2 MONITOR

    K Number: K062468 · Decision Sep 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    20

    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
    SPECTRUM M2 MONITOR
    K Number
    K062468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Medical, Llp
    Date Received
    August 24, 2006
    Decision Date
    September 13, 2006
    Product Code
    DRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    CDI OneView Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    B-Capta

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Workstation 12 Elite

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CDI Blood Parameter Monitoring System 550

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Workstation 12.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

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

    Other Clearances by Spectrum Medical, Llp

    K Number Device Name
    K110957 M4 MONITOR