MODEL AFR EEG TELEPHONE RECEIVER

Encephalogram Telemetry System

TELEDIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Model Afr Eeg Telephone Receiver.

Pre-market Notification Details

Device IDK802657
510k NumberK802657
Device Name:MODEL AFR EEG TELEPHONE RECEIVER
ClassificationEncephalogram Telemetry System
Applicant TELEDIAGNOSTIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGYE  
CFR Regulation Number882.1855 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-24
Decision Date1980-11-12

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