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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
AN
Reference & Predicate Devices
N/A
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.

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).