PENTAX Medical EPK-3000 Imaging System With Camera Head PVK-J10, PENTAX Medical ENT Imaging System With Camera Head PVK-J10

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 Epk-3000 Imaging System With Camera Head Pvk-j10, Pentax Medical Ent Imaging System With Camera Head Pvk-j10.

Pre-market Notification Details

Device IDK220465
510k NumberK220465
Device Name:PENTAX Medical EPK-3000 Imaging System With Camera Head PVK-J10, PENTAX Medical ENT Imaging System With Camera Head PVK-J10
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  
Subsequent Product CodeEQL
Subsequent Product CodeOUG
Subsequent Product CodePEA
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-17
Decision Date2022-11-16

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