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FDA 510(k), K192889, Neo
FDA 510(k), K192889, Neo
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510(K) Number: K192889
Device Name: Neo
Manufacturer: eemagine Medical Imaging Solutions GmbH
Device Classification Name: amplitude-integrated electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 10/10/2019
Decision Date: 01/30/2020
Regulation Medical Specialty: Neurology
Device Name: Neo
Manufacturer: eemagine Medical Imaging Solutions GmbH
Device Classification Name: amplitude-integrated electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 10/10/2019
Decision Date: 01/30/2020
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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