EVOKED RESPONSE STIMULATORS

Conditioner, Signal, Physiological

BIO-LOGIC SYSTEMS CORP.

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

Pre-market Notification Details

Device IDK803226
510k NumberK803226
Device Name:EVOKED RESPONSE STIMULATORS
ClassificationConditioner, Signal, Physiological
Applicant BIO-LOGIC SYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGWK  
CFR Regulation Number882.1845 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-19
Decision Date1981-02-05

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