510(k) K970659

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER by Telediagnostic Systems, Inc. — Product Code GYE

K970659 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER". The FDA issued a decision of Substantially Equivalent on May 16, 1997. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.