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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CAIRD TECHNOLOGY SPIROMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a spirometer system. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt. The letter is an administrative notice of clearance, not a technical report or study summary.

    Therefore, I cannot extract the requested information from this document.

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