EEG TELEPHONE RECEIVER MODEL #AFR-J

Transmitters And Receivers, Electrocardiograph, Telephone

TELEDIAGNOSTIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK810872
510k NumberK810872
Device Name:EEG TELEPHONE RECEIVER MODEL #AFR-J
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant TELEDIAGNOSTIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-31
Decision Date1981-05-01

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