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

    REKA E100

    K Number: K111438 · Decision Sep 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    1
    Review Days
    111

    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
    REKA E100
    K Number
    K111438
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reka Pte, Ltd.
    Date Received
    May 24, 2011
    Decision Date
    September 12, 2011
    Product Code
    DPS
    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
    DPS Electrocardiograph

    Similar 510(k) Clearances

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

    MAC 7 Resting ECG Analysis System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AccurECG Analysis System (v2.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Withings BeamO (SCT02)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cardiologs Holter Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZBPro Diagnostic

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masimo W1

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