FDA 510(k), K171581, Neuro Omega System

FDA 510(k), K171581, Neuro Omega System

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K171581
Device Name: Neuro Omega System
Manufacturer: Maysana Mousa
Device Classification Name: Electrode, Depth
Regulation Number: GZL
Classification Product Code: KXA
Date Received: 05/31/2017
Decision Date: 12/22/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
  • 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.

View full details