END 200 Endoscopic Tubeset

Insufflator, Automatic Carbon-dioxide For Endoscope

Palliare Ltd.

The following data is part of a premarket notification filed by Palliare Ltd. with the FDA for End 200 Endoscopic Tubeset.

Pre-market Notification Details

Device IDK202922
510k NumberK202922
Device Name:END 200 Endoscopic Tubeset
ClassificationInsufflator, Automatic Carbon-dioxide For Endoscope
Applicant Palliare Ltd. Galway Business Park, Dangan Galway,  IE H91 P2dk
ContactJohn O’dea
CorrespondentPaul Dryden
Palliare Ltd. C/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeFCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-07-08

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