PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

Endoscopic Ultrasound System, Gastroenterology-urology

PENTAX OF AMERICA, INC.

The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Eg-3870utk Ultrasound Video Gastroscope + Hi Vision Preirus.

Pre-market Notification Details

Device IDK130247
510k NumberK130247
Device Name:PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale,  NJ  07645
ContactKrishna Govindarajan
CorrespondentKrishna Govindarajan
PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale,  NJ  07645
Product CodeODG  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-01
Decision Date2013-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333232567 K130247 000
04961333228409 K130247 000
04961333113545 K130247 000
04961333123346 K130247 000
04961333083138 K130247 000

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