PENTAX Medical ENT Video Imaging System

Nasopharyngoscope (flexible Or Rigid)

PENTAX Of America, Inc.

The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ent Video Imaging System.

Pre-market Notification Details

Device IDK183691
510k NumberK183691
Device Name:PENTAX Medical ENT Video Imaging System
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactWilliam Goeller
CorrespondentWilliam Goeller
PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-31
Decision Date2019-06-12

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