PENTAX Medical EPK-3000 Video Imaging System

Nasopharyngoscope (flexible Or Rigid)

Pentax Medical

The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Epk-3000 Video Imaging System.

Pre-market Notification Details

Device IDK172156
510k NumberK172156
Device Name:PENTAX Medical EPK-3000 Video Imaging System
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant Pentax Medical 3 Paragon Drive Montvale,  NJ  07645
ContactWilliam Goeller
CorrespondentJames W. Monroe
Pentax Medical 3 Paragon Drive Montvale,  NJ  07645
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-18
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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