Peak Flow Meter

• K Number: K241338
• Device Name: Peak Flow Meter
• Manufacturer: Chongqing Moffy Innovation Technology Co.,Ltd.
• Date Cleared: 2024-12-31 ( 232 days)
• Product Code: BZH
• Regulation Number: 868.1860
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter for a Peak Flow Meter, not an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, such as details on a test set, expert ground truth, MRMC studies, or training data. The document focuses on regulatory compliance and substantial equivalence to predicate devices for a physical medical device.

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).