COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)

• K Number: K013752
• Device Name: COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
• Manufacturer: MORGAN SCIENTIFIC, INC.
• Date Cleared: 2002-01-30 ( 78 days)
• Product Code: BZG
• Regulation Number: 868.1840
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The ComPAS software is intended to operate with the ScreenStar pneumotachograph The Oomr AS sonward to intended to tpon the ScreenStar to display the flow and volume spiromotor: Gomi FD doo hy from patient effort. This information is formatted for use in pulmonary function testing and reports.

Device Description

ComPAS (computerized Pulmonary Analysis Sysem)

AI/ML Overview

I am sorry, but based on the provided text, the document is a 510(k) clearance letter for the ComPAS (computerized Pulmonary Analysis System) software. It affirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the detailed study information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any information about a multi-reader multi-case study, or standalone performance. The letter refers to indications for use but does not delve into the specifics of the testing methodology or results.

Regulation Number and Section

§ 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).