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FDA 510(k), K092625, WAVESTATE NEUROMONITOR
FDA 510(k), K092625, WAVESTATE NEUROMONITOR
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510(K) Number: K092625
Device Name: WAVESTATE NEUROMONITOR
Manufacturer: E.J. Smith
Device Classification Name: Burst Suppression Detection Software For Electroencephalograph
Regulation Number: ORT
Classification Product Code: 08/27/2009
Date Received: 06/29/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: WAVESTATE NEUROMONITOR
Manufacturer: E.J. Smith
Device Classification Name: Burst Suppression Detection Software For Electroencephalograph
Regulation Number: ORT
Classification Product Code: 08/27/2009
Date Received: 06/29/2010
Decision Date: Substantially Equivalent (SESE)
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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