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

    COLIN PRESS MATE, MODEL BP S510

    K Number: K063690 · Decision May 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    68
    Review Days
    148

    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
    COLIN PRESS MATE, MODEL BP S510
    K Number
    K063690
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omron Healthcare, Inc.
    Date Received
    December 12, 2006
    Decision Date
    May 9, 2007
    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 Omron Healthcare, Inc.

    K Number Device Name
    DEN230076 Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))
    K202228 Omron Model BP7900 Blood Pressure Monitor + EKG
    K183215 Focus TENS Therapy, Model PM710-M/-L
    K190693 HEM-6410T-ZL Wrist Blood Pressure Monitor
    K182579 Omron Model BP7900 Blood Pressure Monitor + EKG
    K182120 Maxpower Relief
    K181992 Heat Pain Pro
    K182481 HEM-6410T-ZM Wrist Blood Pressure Monitor
    K182166 Wrist Blood Pressure Monitor Model BP4350
    K182127 Wrist Blood Pressure Monitor Model BP6100
    Search all 68 clearances from Omron Healthcare, Inc. →