FDA 510(k), K140552, CADWELL SPIKE AND SEIZURE DETECTOR

FDA 510(k), K140552, CADWELL SPIKE AND SEIZURE DETECTOR

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510(K) Number: K140552
Device Name: CADWELL SPIKE AND SEIZURE DETECTOR
Manufacturer: CADWELL
Device Classification Name: automatic event detection software for full-montage electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 03/04/2014
Decision Date: 07/23/2014
Regulation Medical Specialty: Neurology
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