AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

Pump, Air, Non-manual, For Endoscope

United State Endoscopy Group, Inc.

The following data is part of a premarket notification filed by United State Endoscopy Group, Inc. with the FDA for Aquashield System - Pentax, Aquashield System Co2 - Pentax, Aquashield System Co2 - Fujinon.

Pre-market Notification Details

Device IDK163424
510k NumberK163424
Device Name:AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
ClassificationPump, Air, Non-manual, For Endoscope
Applicant United State Endoscopy Group, Inc. 5976 Heisley Rd. Mentor,  OH  44060
ContactGanga Kolli
CorrespondentGanga Kolli
United State Endoscopy Group, Inc. 5976 Heisley Rd. Mentor,  OH  44060
Product CodeFEQ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-06
Decision Date2017-01-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10816765013332 K163424 000
10816765013318 K163424 000
10724995183889 K163424 000
10724995183872 K163424 000
10724995183865 K163424 000

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