PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)

Gastroscope And Accessories, Flexible/rigid

PENTAX MEDICAL COMPANY

The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentax Video Upper G.i. Scopes (eg Family).

Pre-market Notification Details

Device IDK131902
510k NumberK131902
Device Name:PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale,  NJ  07645
ContactKrishna Govindarajan
CorrespondentKrishna Govindarajan
PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale,  NJ  07645
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-25
Decision Date2014-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333243372 K131902 000
04961333225026 K131902 000
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04961333223022 K131902 000
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04961333084029 K131902 000
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04961333232512 K131902 000
04961333232482 K131902 000
04961333232475 K131902 000
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04961333228478 K131902 000
04961333227099 K131902 000
04961333227044 K131902 000
04961333225743 K131902 000
04961333070466 K131902 000

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