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FDA 510(k) K010728, HARMONE-SCHWARZER EEG SYSTEM, by Stellate Systems

FDA 510(k) K010728, HARMONE-SCHWARZER EEG SYSTEM, by Stellate Systems

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510(K) Number: K010728
Device Name: HARMONE-SCHWARZER EEG SYSTEM
Manufacturer: Stellate Systems
Device Classification Name: standard polysomnograph with electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OLV
Date Received: 03/12/2001
Decision Date: 05/21/2001
Regulation Medical Specialty: Neurology
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