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

    HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX

    K Number: K031167 · Decision Jan 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    6
    Review Days
    289

    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
    HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
    K Number
    K031167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Idt Technology Limited
    Date Received
    April 14, 2003
    Decision Date
    January 28, 2004
    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 Idt Technology Limited

    K Number Device Name
    K151415 Oregon Scientific
    K131245 OREGON SCINTIFIC
    K050083 BLOOD-PRESSURE METER, BPW120
    K020433 FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
    K021252 BLOOD-PRESSURE METER