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

    Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

    K Number: K241431 · Decision Jan 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    22
    Review Days
    237

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    Basic Information

    Device Name
    Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
    K Number
    K241431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joytech Healthcare Co. , Ltd.
    Date Received
    May 21, 2024
    Decision Date
    January 13, 2025
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Joytech Healthcare Co. , Ltd.

    K Number Device Name
    K252501 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
    K252685 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
    K243468 Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
    K250548 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
    K241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
    K231303 Arm-type Fully Automatic Digital Blood Pressure Monitor
    K230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K213189 Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K200649 Arm-Type Fully Automatic Digital Blood Pressure Monitor
    Search all 22 clearances from Joytech Healthcare Co. , Ltd. →