FDA 510(k), K080788, VIVASCOPE SYSTEM, MODEL 1500, 3000

FDA 510(k), K080788, VIVASCOPE SYSTEM, MODEL 1500, 3000

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K080788
Device Name: VIVASCOPE SYSTEM, MODEL 1500, 3000
Manufacturer: JAMES JOY
Device Classification Name: Light Based Imaging
Regulation Number: PSN
Classification Product Code: KXA
Date Received: 03/20/2008
Decision Date: 09/17/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • 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