LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990517
    Device Name
    EXPLORER CVS TRANSCRANIAL DOPPLER
    Manufacturer
    DIAGNOSTIC MEDICAL SYSTEMS
    Date Cleared
    2000-08-01

    (530 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer CVS device is intended to be used to produce images of peripheral and intracranial vasculature to be analysed by trained medical personnel for assessment and diagnosis of vascular status and disorders. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Neonatal Cephalic (PWD); Peripheral Vascular (PWD, CWD) Adult Cephalic (B, M) Intravascular (PWD, CWD); Peripheral Vascular (PWD, CWD) Intravascular (CWD); Peripheral Vascular (PWD, CWD)
    Device Description
    The Explorer CVS device is a diagnostic ultrasonic Doppler. The Explorer CVS Doppler device utilizes multiple frequencies of transducers to provide high resolution images.
    Ask a Question

    Page 1 of 1