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510(k) Data Aggregation

    K Number
    K242487
    Device Name
    Laminar P1 (LDH-HW-001)
    Manufacturer
    Laminar Digital Health, Inc.
    Date Cleared
    2024-12-13

    (114 days)

    Product Code
    JAF, DPW
    Regulation Number
    892.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laminar Digital Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.
    Device Description
    The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.
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