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

    WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20

    K Number: K031582 · Decision Aug 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    21
    Review Days
    72

    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
    WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
    K Number
    K031582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Seimitsu Sokki Co., Ltd.
    Date Received
    May 21, 2003
    Decision Date
    August 1, 2003
    Product Code
    MNW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MNW Analyzer, Body Composition

    Similar 510(k) Clearances

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

    Multi-parameter detector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOSPACE BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARIA WIFI SMART SCALE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BODY FAT ANALYZER AND SCALE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIA / VITALITY ANALYZER

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

    Other Clearances by Nihon Seimitsu Sokki Co., Ltd.

    K Number Device Name
    K112620 DISITAL BLOOD PRESSURE MONITOR
    K112690 BLOOD PRESSURE MONITOR
    K112691 BLOOD PRESSURE MONITOR
    K093102 AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
    K080177 WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
    K071596 POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
    K071384 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
    K061086 DM-3000 DIGITAL BLOOD PRESSURE MONITOR
    K050697 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
    K040309 DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
    Search all 21 clearances from Nihon Seimitsu Sokki Co., Ltd. →