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

    PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403

    K Number: K862647 · Decision Aug 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    27
    Review Days
    38

    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
    PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
    K Number
    K862647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ivy Biomedical Systems, Inc.
    Date Received
    July 11, 1986
    Decision Date
    August 18, 1986
    Product Code
    DSK
    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
    DSK Computer, Blood-Pressure

    Similar 510(k) Clearances

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

    Endophys Blood Pressure Monitor model BPM-30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endophys Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOPHYS BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

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

    Other Clearances by Ivy Biomedical Systems, Inc.

    K Number Device Name
    K240087 RT Carbon ECG Leads
    K202138 Cardiac Trigger Monitor
    K203653 MRI PPG Patient Cable
    K192852 MRI ECG Patient Cable
    K171778 MR Wireless Gating System, Model WGS-100
    K170828 Cardiac Trigger Monitor
    K151781 Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
    K110987 CARDIAC TRIGGER MONITOR
    K091787 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
    K091985 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
    Search all 27 clearances from Ivy Biomedical Systems, Inc. →