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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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