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510(k) Data Aggregation

    K Number
    K232772
    Device Name
    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)
    Manufacturer
    Shenzhen Plinma Technology Co. Ltd.
    Date Cleared
    2023-11-29

    (79 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Plinma Technology Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its usage. Reusable Blood Pressure Cuff models: 1201B1,12L2B1,1202B1,12L3B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,1207B1- 3#,1207B1-4#,1207B15#,1201W2,12L2W2,1202W2,12L3W2,1203W2, 1204W2,1205W2,1206W2 and 1207W2 Disposable Blood Pressure Cuff models: 1201D1,12L2D1,1202D1,12L3D1,1204D1,1205D1,1204D1,1207D1-1#,1207D1-2#,1207D1- 3#,1207D1-4#,1207D1-5# Connector models: PLINMA-03-127-003, PLINMA-03-T, PLINMA-03-Z3
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