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K Number
K042595
Device Name
SPIRO'AIR
Manufacturer
MORGAN SCIENTIFIC, INC.
Date Cleared
2005-05-04

(223 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

The SpiroAir PFT System is intended to operate with the ComPAS pulmonary function software. ComPAS uses flow and volume from the SpiroAir to display the flow and volume information and to generate reports. ComPAS utilizes gas analysis from the SpiroAir to display single breath diffusion data and to generate reports.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the SpiroAir PFT System, a diagnostic spirometer. It does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt.

The letter primarily:

  • Confirms the device's substantial equivalence to a predicate device.
  • Outlines general regulatory requirements.
  • States the indications for use.

Therefore, I cannot provide the requested information from the provided text. The document is administrative, not a technical report detailing performance studies.

§ 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).