BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Enhanced External Counter Pulsation Device Plus Omay-A

    K Number: K191955 · Decision Aug 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    380

    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
    Enhanced External Counter Pulsation Device Plus Omay-A
    K Number
    K191955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omay(Guangzhou)Med Technologies Co., Ltd.
    Date Received
    July 22, 2019
    Decision Date
    August 5, 2020
    Product Code
    DRN
    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
    DRN Device, Counter-Pulsating, External

    Similar 510(k) Clearances

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

    Pression Wave PRO External Counter-Pulsation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    External Counterpulsation System, Soulaire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    External Counterpulsation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pure Flow External Counter-Pulsation Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Renew NCP-5 External Counterpulsation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

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