AUDIOMETER

Calibrator, Hearing Aid / Earphone And Analysis Systems

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Audiometer.

Pre-market Notification Details

Device IDK870337
510k NumberK870337
Device Name:AUDIOMETER
ClassificationCalibrator, Hearing Aid / Earphone And Analysis Systems
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactRaviv, Ph.d.
CorrespondentRaviv, Ph.d.
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeETW  
CFR Regulation Number874.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-28
Decision Date1987-04-16

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