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

    AGILENT M2636B TELEMON B MONITOR (TELEMON B)

    K Number: K011824 · Decision Jul 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    30
    Review Days
    21

    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
    AGILENT M2636B TELEMON B MONITOR (TELEMON B)
    K Number
    K011824
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies, Inc.
    Date Received
    June 11, 2001
    Decision Date
    July 2, 2001
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

    Similar 510(k) Clearances

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

    BodyGuardian Remote Monitoring System (BGRMS v3.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartCardia 7L Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unified Arrhythmia Diagnostic System PocketECG IV

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

    Other Clearances by Agilent Technologies, Inc.

    K Number Device Name
    K163367 GenetiSure Dx Postnatal Assay
    K012094 MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
    K010634 HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
    K011578 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K003819 HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
    K011093 AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
    K010453 M2376A DEVICELINK SYSTEM
    K010342 M2376A DEVICELINK SYSTEM, MODEL M2376A
    K010048 M2376A DEVICELINK SYSTEM
    K003565 HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
    Search all 30 clearances from Agilent Technologies, Inc. →