FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.

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I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, indicating the clearance of a device based on substantial equivalence. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. Therefore, I cannot generate the table and detailed study description you've asked for based on this document.

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K Number

K970659

Device Name

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

Manufacturer

TELEDIAGNOSTIC SYSTEMS, INC.

Date Cleared

1997-05-16

(84 days)

Product Code