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FDA 510(k), K170138, NEURONAUTE
FDA 510(k), K170138, NEURONAUTE
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510(K) Number: K170138
Device Name: NEURONAUTE
Manufacturer: Quang TRAN
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: GWQ
Classification Product Code: 01/17/2017
Date Received: 12/26/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: NEURONAUTE
Manufacturer: Quang TRAN
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: GWQ
Classification Product Code: 01/17/2017
Date Received: 12/26/2017
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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