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

    CARDIO DATA PACEMAKER RECORDER

    K Number: K831184 · Decision May 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    6
    Review Days
    28

    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
    CARDIO DATA PACEMAKER RECORDER
    K Number
    K831184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardio Data
    Date Received
    April 11, 1983
    Decision Date
    May 9, 1983
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

    Similar 510(k) Clearances

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

    Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitaloJAK Clinic (Model 7100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zio® monitor (DFG0001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AeviceMD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AT-Patch (ATP-C130/ATP-C70)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HiCardi+ H100

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

    Other Clearances by Cardio Data

    K Number Device Name
    K853262 CARDIO DATA PACERECORDER PR3
    K850136 CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
    K834257 CARDIODATA PACE RECORDER
    K812149 CARDIO-DATA SYSTEM, #MARK III
    K770264 PACEGUARD