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FDA 510(k) Applications Submitted by PENTAX Medical
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171011
04/04/2017
PENTAX Medical VIVIDEO ENT Videoscope Solution
Pentax Medical
K161222
04/29/2016
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
PENTAX MEDICAL
K163614
12/22/2016
PENTAX Medical ED34-i10T, Video Duodenoscope
PENTAX Medical
K122470
08/13/2012
PENTAX EPK-I5010 VIDEO PROCESSOR
PENTAX MEDICAL
K172156
07/18/2017
PENTAX Medical EPK-3000 Video Imaging System
Pentax Medical
K192280
08/22/2019
PENTAX Medical ED-3490TK Video Duodenoscope
Pentax Medical
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