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

    MINISCOPE MS-2B ELECTROCARDIOSCOPE

    K Number: K791421 · Decision Aug 28, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    570
    Applicant Total
    4
    Review Days
    43

    Basic Information

    Device Name
    MINISCOPE MS-2B ELECTROCARDIOSCOPE
    K Number
    K791421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    RENESCO INTERNATIONAL, INC.
    Date Received
    July 16, 1979
    Decision Date
    August 28, 1979
    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.

    ZBPro Diagnostic

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masimo W1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CloudHRV™ System (100-01-001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cardiac Workstation (5000); Cardiac Workstation (7000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masimo W1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeepRhythm Platform

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

    Other Clearances by RENESCO INTERNATIONAL, INC.

    K Number Device Name
    K800659 SCHILLER MSG-1
    K791422 MINISPIROMETER SP-1
    K791420 MINIGRAPH MG-I ELECTROCARDIOGRAPH