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K Number
K150515
Device Name
IQSense Flow Sensor Mouthpiece
Manufacturer
SDI DIAGNOSTICS, INC.
Date Cleared
2016-01-12

(316 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 IQSense Flow Sensor Mouthpiece is intended to be used as a disposable pneumotach mouthpiece for the Midmark (formerly Brentwood) IQspiro Digital Spirometer.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K150515 for the "IOSense Flow Sensor Mouthpiece" is a clearance letter and an "Indications for Use" statement. It does not contain information about the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information based on the given text.

To answer your request, I would need a document such as the 510(k) summary or the full 510(k) submission, which typically includes detailed study reports and performance data.

§ 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).