Brentwood Instruments, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 21
What Brentwood Instruments, Inc. makes
Brentwood Instruments, Inc. manufactures electrocardiograph (ECG) devices, including single-channel, three-channel, and automated models for cardiac monitoring, as well as ECG transmitters and receivers for remote patient data transmission. Their portfolio also includes rhythm analysis systems and spirometry devices for respiratory function assessment, designed for clinical and diagnostic use.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway, indicating they meet U.S. regulatory standards for medical devices. These products are intended for use within the United States, adhering to FDA compliance requirements for diagnostic and monitoring equipment.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Brentwood Instruments, Inc. have in the registry?
The registry currently lists 21 devices for Brentwood Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brentwood Instruments, Inc.'s devices?
Among its 21 most recently registered devices, Brentwood Instruments, Inc. has devices listed in FDA 510(k) (21 devices).
What risk classes do Brentwood Instruments, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Brentwood Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Brentwood Instruments, Inc. in the registry?
The most recently registered devices listed for Brentwood Instruments, Inc. include FUKUDA DENSHI MODEL FCP-220, COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200, RHYTHMSCAN and FUKUDA DENSHI CARDIMAX FCP-211.