AP-CHECK

Tester, Electrode/lead, Electroencephalograph

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Ap-check.

Pre-market Notification Details

Device IDK830877
510k NumberK830877
Device Name:AP-CHECK
ClassificationTester, Electrode/lead, Electroencephalograph
Applicant GENERAL DEVICES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGYA  
CFR Regulation Number882.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-18
Decision Date1983-06-08

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