LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K101016
    Device Name
    ANS SYSTEM
    Manufacturer
    CAIRD TECHNOLOGY
    Date Cleared
    2011-01-28

    (291 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRD TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K012686
    Device Name
    CAIRD TECHNOLOGY HOLTER 2000
    Manufacturer
    CAIRD TECHNOLOGY
    Date Cleared
    2001-12-13

    (121 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRD TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Designed for Adult and Pediatric Patients. - For Hospital and Clinic use only. - For Prescription use only. Some of the conditions for use are as follows: - Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. - Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. - Evaluation of patients for ST segment Changes - Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). - Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. - Clinical and epidemiological research studies.
    Device Description
    Not Found
    Ask a Question
    K Number
    K971336
    Device Name
    CAIRD TECHNOLOGY SPIROMETER
    Manufacturer
    CAIRD TECHNOLOGY
    Date Cleared
    1998-12-01

    (600 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRD TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Use - Designed for Adult and Pediatric Patients. - For Hospital and Clinic use only. - For Prescription use only. Some of the conditions for use are as follows: - Shortness of Breath . - . Chronic Cough - Occupational Exposure to Dust or Chemicals ● - Assist in the Diagnosis of Bronchitis . - Assist in the Diagnosis of Asthma . - Wheezing . - Assist in the monitoring of Bronodialators .
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1