AutoZone Peak Flow Meter
510(k) K952909
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952909 | Date29 Mar 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Autozone
- 510(k) Number
- FDA Product Code
- BZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1860
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The AutoZone is a Peak Expiratory Flow Meter, a diagnostic device used to measure the maximum speed of exhaled air from the lungs. It is classified under the FDA’s Anesthesiology category and is designed to assist in the assessment of respiratory function, particularly in monitoring conditions such as asthma or chronic obstructive pulmonary disease (COPD). The device provides quantitative data to help evaluate lung capacity and airflow obstruction, supporting clinical decision-making in respiratory care.
This device is supplied as a single-use or reusable instrument, depending on the model, and is regulated under FDA 510(k) clearance (K952909) with product code BZH. It is intended for use in clinical settings, including hospitals, physician offices, and home monitoring environments. The device adheres to FDA regulation 868.1860 and is classified as a Class II medical device. Storage and handling instructions are specified in the manufacturer’s documentation, though no additional sterility claims are stated in the regulatory data.
Other devices from Health Scan, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the AutoZone Peak Expiratory Flow Meter used for?
The AutoZone Peak Expiratory Flow Meter is designed to measure the maximum speed of exhaled air from the lungs, helping assess respiratory function. It is particularly useful in monitoring conditions like asthma or chronic obstructive pulmonary disease (COPD) by providing quantitative data on lung capacity and airflow obstruction. This supports clinical decision-making in respiratory care settings.
Is the AutoZone Peak Expiratory Flow Meter single-use or reusable?
The AutoZone Peak Expiratory Flow Meter can be supplied as either single-use or reusable, depending on the specific model. The manufacturer’s documentation outlines storage and handling instructions, but no additional sterility claims are explicitly stated in the regulatory data. Always refer to the provided instructions for proper use and maintenance.
What regulatory approval does the AutoZone Peak Expiratory Flow Meter hold?
The AutoZone Peak Expiratory Flow Meter is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K952909. It falls under the Anesthesiology category and is classified as a Class II medical device, adhering to FDA regulation 868.1860. This device is intended for use in clinical settings, including hospitals, physician offices, and home monitoring environments.
Are there different models or sizes available for the AutoZone Peak Expiratory Flow Meter?
Multiple registration numbers indicate that the AutoZone Peak Expiratory Flow Meter may come in various models or configurations, as listed under the OpenFDA data. These variations could include differences in design or functionality, but specific details on sizes or model distinctions are not provided in the regulatory data. For precise information, consult the manufacturer’s documentation.
How should the AutoZone Peak Expiratory Flow Meter be stored?
Storage instructions for the AutoZone Peak Expiratory Flow Meter are detailed in the manufacturer’s documentation provided with the device. While no specific sterility claims are mentioned in the regulatory data, proper storage is essential to maintain accuracy and functionality. Always follow the guidelines to ensure optimal performance and longevity of the device.