FDA 510(k), K182967, Visor System

FDA 510(k), K182967, Visor System

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K182967
Device Name: Visor System
Manufacturer: Dawnel Scott
Device Classification Name: Impedance Plethysmograph, Cranial
Regulation Number: QAF
Classification Product Code: KXA
Date Received: 10/26/2018
Decision Date: 11/23/2018
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