Neurotronics, LLC - FDA 510(k) Cleared Devices

Neurotronics, LLC is a medical device company specializing in sleep diagnostics and anesthesiology devices, with a manufacturing facility in Alachua, US. The company develops advanced diagnostic software, sensors, and monitoring equipment for sleep medicine and clinical applications.

Neurotronics has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus is entirely within anesthesiology devices. The first and latest clearance occurred in 2025, reflecting active regulatory engagement.

The company's product portfolio includes Polysmith sleep diagnostic software with patient scheduling and automated analysis capabilities, Neurotronics Sensors for high-quality signal acquisition, the Sphinx PMU710 sleep amplifier with integrated oximetry, and Live View Panel remote monitoring technology. These products support comprehensive sleep study workflows and multi-facility neuromonitoring operations.

Explore the company's cleared device names, product codes, and clearance dates in the 510(k) database.