FDA 510(k), K193007, LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

510(K) Number: K193007
Device Name: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
Manufacturer: Jaroslaw Mrówczynski
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: HIH
Classification Product Code: KXA
Date Received: 10/28/2019
Decision Date: 01/17/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology

• Total Pages: 673
• Fully Redacted Pages: 401
• Content Pages: 272 (Total pages minus fully redacted pages)