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

    CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE

    K Number: K090014 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    175
    Registration Numbers
    175
    Same Product Code
    192
    Applicant Total
    2
    Review Days
    97

    Basic Information

    Device Name
    CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
    K Number
    K090014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CAREMATE MEDICAL DEVICE CO., LTD
    Date Received
    January 2, 2009
    Decision Date
    April 9, 2009
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

    Similar 510(k) Clearances

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

    Disposable Blood Pressure cuff; Reusable Blood Pressure cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reusable Blood Pressure Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIBPCuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aneroid Sphygmomanometer

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

    Other Clearances by CAREMATE MEDICAL DEVICE CO., LTD

    K Number Device Name
    K102792 DISPOSABLE BLOOD PRESSURE CUF