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

    Laminar P1 (LDH-HW-001)

    K Number: K242487 · Decision Dec 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    Laminar P1 (LDH-HW-001)
    K Number
    K242487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laminar Digital Health, Inc.
    Date Received
    August 21, 2024
    Decision Date
    December 13, 2024
    Product Code
    JAF
    Advisory Committee
    Radiology
    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
    JAF Monitor, Ultrasonic, Nonfetal

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