New England Medical Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What New England Medical Instruments, Inc. makes
New England Medical Instruments, Inc. manufactures portable and home-use electroencephalogram (EEG) monitoring systems, including standalone EEG recorders and video-EEG combinations for ambulatory patient monitoring. Their devices are designed for long-term seizure detection and neurological event recording, supporting both clinical and home-based diagnostic applications.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Digitrace Home Video System Ref K955787
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New England Medical Instruments, Inc. have in the registry?
The registry currently lists 3 devices for New England Medical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New England Medical Instruments, Inc.'s devices?
Among its 3 most recently registered devices, New England Medical Instruments, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do New England Medical Instruments, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for New England Medical Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New England Medical Instruments, Inc. in the registry?
The most recently registered devices listed for New England Medical Instruments, Inc. include DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX, MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER and DIGITRACE HOME VIDEO SYSTEM.