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    K160349 510K信（WBP100 WBP201 WBP202）

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    Vivis Dias
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    K160349 510K信（WBP100 WBP201 WBP202）

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    Vivis Dias
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    123

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    123

    Copyright:

    © All Rights Reserved
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    Download as pdf or txt
    10 views2 pages

    K160349 510K信（WBP100 WBP201 WBP202）

    Uploaded by

    Vivis Dias
    123

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 2

    DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

    Food and Drug Administration


    10903 New Hampshire Avenue
    Document Control Center - WO66-G609
    November 3, 2016 Silver Spring, MD 20993-0002

    Guangdong Biolight Meditech Co., Ltd.


    ℅ Diana Hong
    General Manager
    Mid-Link Consulting Co., Ltd
    P.O. Box 120-119
    Shanghai, 200120 CN

    Re: K160349
    Trade/Device Name: Electronic Sphygmomanometer
    Regulation Number: 21 CFR 870.1130
    Regulation Name: Noninvasive Blood Pressure Measurement System
    Regulatory Class: Class II
    Product Code: DXN
    Dated: September 25, 2016
    Received: September 28, 2016

    Dear Diana Hong:

    We have reviewed your Section 510(k) premarket notification of intent to market the device
    referenced above and have determined the device is substantially equivalent (for the indications
    for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
    commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
    devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
    and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
    You may, therefore, market the device, subject to the general controls provisions of the Act. The
    general controls provisions of the Act include requirements for annual registration, listing of
    devices, good manufacturing practice, labeling, and prohibitions against misbranding and
    adulteration. Please note: CDRH does not evaluate information related to contract liability
    warranties. We remind you, however, that device labeling must be truthful and not misleading.

    If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
    it may be subject to additional controls. Existing major regulations affecting your device can be
    found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
    publish further announcements concerning your device in the Federal Register.

    Please be advised that FDA's issuance of a substantial equivalence determination does not mean
    that FDA has made a determination that your device complies with other requirements of the Act
    or any Federal statutes and regulations administered by other Federal agencies. You must comply
    with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
    Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
    related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
    Page 2 - Diana Hong

    the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
    radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

    If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
    contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
    or (301) 796-7100 or at its Internet address
    http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
    the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
    807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
    CFR Part 803), please go to
    http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
    of Surveillance and Biometrics/Division of Postmarket Surveillance.

    You may obtain other general information on your responsibilities under the Act from the
    Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
    796-7100 or at its Internet address
    http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

    Sincerely yours,

    Bram D. Zuckerman, M.D.


    Director
    Division of Cardiovascular Devices
    Office of Device Evaluation
    Center for Devices and Radiological Health

    Enclosure

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