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FDA 510(k), K141883, CLINISCANSM EEG
FDA 510(k), K141883, CLINISCANSM EEG
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510(K) Number: K141883
Device Name: CLINISCANSM EEG
Manufacturer: PICOFEMTO LLC
Device Classification Name: automatic event detection software for full-montage electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 07/11/2014
Decision Date: 05/15/2015
Regulation Medical Specialty: Neurology
Device Name: CLINISCANSM EEG
Manufacturer: PICOFEMTO LLC
Device Classification Name: automatic event detection software for full-montage electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 07/11/2014
Decision Date: 05/15/2015
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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