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

    VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07

    K Number: K011540 · Decision Feb 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    136
    Review Days
    264

    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
    VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
    K Number
    K011540
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datascope Corp.
    Date Received
    May 18, 2001
    Decision Date
    February 6, 2002
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    Similar 510(k) Clearances

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

    Radius VSM and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M12 Telemetry System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista CMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

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

    Other Clearances by Datascope Corp.

    K Number Device Name
    K190884 TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
    K181122 CARDIOSAVE Intra-Aortic Balloon Pump
    K172305 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
    K163542 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
    K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
    K133074 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
    K071805 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
    K062569 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
    K062098 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
    K063525 DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
    Search all 136 clearances from Datascope Corp. →