FDA 510(k), K152547, DNAP Electrode
FDA 510(k), K152547, DNAP Electrode
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510(K) Number: K152547
Device Name: DNAP Electrode
Manufacturer: Lisa Theama
Device Classification Name: Electrode, Depth
Regulation Number: GZL
Classification Product Code: 09/08/2015
Date Received: 03/04/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: DNAP Electrode
Manufacturer: Lisa Theama
Device Classification Name: Electrode, Depth
Regulation Number: GZL
Classification Product Code: 09/08/2015
Date Received: 03/04/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- 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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