FDA 510(k) Applications Submitted by James W. Monroe

FDA 510(k) Number Submission Date Device Name Applicant
K100236 01/26/2010 STAIR SYSTEMS PACS & DICOM VIEWER STAIR SYSTEMS, INC.
K142054 07/29/2014 IMACOR ZURA EVO IMAGING SYSTEM IMACOR INC.
K180285 02/01/2018 PENTAX Medical Video Colonoscope EC34-i10T Series PENTAX Medical of America, Inc
K180292 02/01/2018 PENTAX Video Upper G.I. Scope EG34-i10 PENTAX Medical of America, Inc
K171011 04/04/2017 PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical
K181084 04/24/2018 PENTAX Video Colonoscopes (EC Family) PENTAX of America, Inc.
K173554 11/17/2017 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope PENTAX of America, Inc.
K173679 12/01/2017 PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes PENTAX of America, Inc.


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