Identifiers
- 510(k) Number
- K241338 FDA 510(k)
- FDA Product Code
- BZH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1860 FDA 510(k)
- Regulation Number
- 868.1860 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Peak Flow Meter is a diagnostic device classified as a Peak Flow Meter under FDA regulation 868.1860. It measures the maximum speed of exhaled air to assess airway obstruction, primarily used in the monitoring of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). This handheld device provides quantitative data on lung function, aiding in the evaluation of respiratory health and treatment efficacy.
This device is intended for single-use or reusable applications in clinical and home settings, depending on the model. Supplied as a Class II medical device, it has received FDA 510(k) clearance under the Traditional pathway, with a decision date of December 31, 2024. The device is not MRI-safe, and its specifications include various registration numbers (e.g., 3034603279) for regulatory tracking. Storage and handling instructions are manufacturer-specific but typically require protection from extreme temperatures and moisture.
Frequently asked questions
What is the Peak Flow Meter used for?
The Peak Flow Meter is a diagnostic device that measures the maximum speed of exhaled air to assess airway obstruction. It is primarily used in monitoring respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), providing quantitative data on lung function to aid in evaluating respiratory health and treatment efficacy.
Is the Peak Flow Meter single-use or reusable?
The Peak Flow Meter can be used as either a single-use or reusable device, depending on the specific model selected. This flexibility allows for use in both clinical settings and home environments, accommodating different patient needs and healthcare provider preferences.
What are the storage requirements for the Peak Flow Meter?
Storage and handling instructions for the Peak Flow Meter are manufacturer-specific but typically require protection from extreme temperatures and moisture. The device should be stored in a clean, dry environment to maintain its functionality and accuracy over time.
What regulatory approvals does the Peak Flow Meter have?
The Peak Flow Meter is classified as a Class II medical device and has received FDA 510(k) clearance under the Traditional pathway with a decision date of December 31, 2024. It is regulated under FDA regulation 868.1860 and is not MRI-safe.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electronic peak flow meter - Moffy Innovation (Chongqing) Technology Co ..., Company Overview - CHONGQING SONMOL TECHNOLOGY CO., LTD., Chongqing Moffy Innovation Technology Co., Ltd. FDA 510(k), Chongqing Moffy Innovation Technology Co., Ltd. - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241338 | Class II | Active |
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Manufacturer
- Manufacturer
- Chongqing Moffy Innovation Technology Co., Ltd.
Sources (1)
- FDA 510(k) K241338 24 fields · synced Oct 1, 2026