BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

• K Number: K002499
• Device Name: BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
• Manufacturer: BRENTWOOD MEDICAL TECHNOLOGY CORP.
• Date Cleared: 2000-11-08 ( 86 days)
• Product Code: BZG
• Regulation Number: 868.1840
• Type: Traditional
• Panel: Anesthesiology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K020102 , K080921 , K090034

Intended Use

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Device Description

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AI/ML Overview

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Summary

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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).