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FDA 510(k), K172890, SedLine Sedation Monitor
FDA 510(k), K172890, SedLine Sedation Monitor
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510(K) Number: K172890
Device Name: SedLine Sedation Monitor
Manufacturer: Masimo Corporation
Device Classification Name: index-generating electroencephalograph software
Regulation Number: 882.1400
Classification Product Code: OLW
Date Received: 09/22/2017
Decision Date: 01/26/2018
Regulation Medical Specialty: Neurology
Device Name: SedLine Sedation Monitor
Manufacturer: Masimo Corporation
Device Classification Name: index-generating electroencephalograph software
Regulation Number: 882.1400
Classification Product Code: OLW
Date Received: 09/22/2017
Decision Date: 01/26/2018
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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