RESPONSE SYSTEM, TN-3000

Amplifier, Physiological Signal

TRACOR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Response System, Tn-3000.

Pre-market Notification Details

Device IDK781743
510k NumberK781743
Device Name:RESPONSE SYSTEM, TN-3000
ClassificationAmplifier, Physiological Signal
Applicant TRACOR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-20
Decision Date1978-12-01

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