Physiometrix, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
What Physiometrix, Inc. makes
Physiometrix, Inc. manufactures electroencephalography (EEG) monitoring systems and accessories, including standalone EEG monitors like the SEDLINE and PSA4000 with frontal PSI, as well as neuromonitoring platforms such as the Neurolink II and Equinox digital EEG systems. Their portfolio also includes electrode arrays (e.g., PSArray2), electrode cables (e.g., E-Net and OR-Net), disposable electrodes (e.g., HydroDot and Drigel), and skin prep solutions (e.g., Hydro Prep). These devices are designed for intraoperative and critical care EEG monitoring in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are subject to 510(k) clearance in the United States. No additional registries or international listings are specified.
Catalogue
Search and filter all 22 devicesFrequently asked questions
How many devices does Physiometrix, Inc. have in the registry?
The registry currently lists 22 devices for Physiometrix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Physiometrix, Inc.'s devices?
Among its 22 most recently registered devices, Physiometrix, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do Physiometrix, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Physiometrix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Physiometrix, Inc. in the registry?
The most recently registered devices listed for Physiometrix, Inc. include SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET, MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM, MODEL 4310 PSARRAY2 EEG ELECTRODE and MODEL 1210, MEDIUM E-NET.