FDA 510(k), K193375, NeuroBlate System

FDA 510(k), K193375, NeuroBlate System

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K193375
Device Name: NeuroBlate System
Manufacturer: David H. Mueller
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 12/05/2019
Decision Date: 01/03/2020
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