FDA 510(k), K002519, VITREA 2, VERSION 2.1

FDA 510(k), K002519, VITREA 2, VERSION 2.1

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K002519
Device Name: VITREA 2, VERSION 2.1
Manufacturer: ROBERT C SAMEC
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 08/15/2000
Decision Date: 10/19/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • 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