AccuTrax, Model EPF840
by Korr Medical Technologies Inc.
510(k) K982995
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982995 | Date4 Dec 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 8 Nov 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZH
- FDA applicant
- Korr Medical Technologies, Inc.
- 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 AccuTrax, Model EPF840 is an electronic peak flow meter designed for measuring peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1). Classified under the nomenclature for Meter, Peak Flow, Spirometry (product code BZH), this device employs a pneumotachometer with a fixed obstruction to generate backpressure, converting airflow into measurable signals via a pressure transducer.
This device is intended for home or workplace use to monitor respiratory function and is regulated under FDA 510(k) clearance (K982995) as a Class II medical device under regulation number 868.1860. It is supplied as a reusable diagnostic instrument and requires no specific sterility measures for its intended use. The device is not labeled for MRI compatibility or other imaging environments. Storage conditions are not specified in the regulatory data.
Other devices from Korr Medical Technologies Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the AccuTrax EPF840 used for?
The AccuTrax EPF840 is designed to measure peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1). These measurements help monitor respiratory function, making it useful for tracking lung health in both home and workplace settings. The device converts airflow into measurable signals using a pneumotachometer with a fixed obstruction and a pressure transducer.
Is the AccuTrax EPF840 single-use or reusable?
The AccuTrax EPF840 is supplied as a reusable diagnostic instrument. Since it is intended for monitoring respiratory function in non-invasive settings, no specific sterility measures are required for its intended use. However, standard hygiene practices should be followed to maintain cleanliness and functionality.
What are the storage requirements for the AccuTrax EPF840?
The regulatory data for the AccuTrax EPF840 does not specify detailed storage conditions. However, it is generally recommended to store electronic medical devices in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of electromagnetic interference to ensure proper functionality and longevity.
Can the AccuTrax EPF840 be used in MRI environments?
No, the AccuTrax EPF840 is not labeled for MRI compatibility or use in other imaging environments. Electronic devices, including this peak flow meter, may pose risks in MRI settings due to potential electromagnetic interference or physical hazards.
What regulatory approval does the AccuTrax EPF840 hold?
The AccuTrax EPF840 is regulated under FDA 510(k) clearance with the clearance number K982995. It is classified as a Class II medical device under regulation number 868.1860 and is substantially equivalent to its predicate device, as determined by the FDA.