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K Number
K013812
Device Name
SPIROLAB II, MODEL 29
Manufacturer
SDI DIAGNOSTICS, INC.
Date Cleared
2002-02-11

(88 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 Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or trained technician to measure lung function in patients of all ages. It can be used in any setting, home, factory, hospital or physician's office.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the SDI Spirolab II Spirometer. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

Therefore, I cannot answer your request based on the provided text.

§ 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).