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

    BODY FAT ANALYZER, MODEL HBF-306

    K Number: K011652 · Decision Nov 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    68
    Review Days
    162

    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
    BODY FAT ANALYZER, MODEL HBF-306
    K Number
    K011652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omron Healthcare, Inc.
    Date Received
    May 29, 2001
    Decision Date
    November 7, 2001
    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 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. →