Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K212830
    Device Name
    CT3000Pro
    Manufacturer
    SRS Medical
    Date Cleared
    2021-12-21

    (105 days)

    Product Code
    FEN, EXQ
    Regulation Number
    876.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRS Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow. The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.
    Device Description
    The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies. The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.
    Ask a Question
    K Number
    K003127
    Device Name
    REGAIN DESKTOP
    Manufacturer
    SRS MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-01-04

    (90 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRS MEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003367
    Device Name
    ORION PLATINUM
    Manufacturer
    SRS MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-01-04

    (66 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRS MEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002834
    Device Name
    SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
    Manufacturer
    SRS MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-11-29

    (78 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRS MEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1