Rapid Barostat Bag (RBB) Pump And Catheter

System, Gastrointestinal Motility (electrical)

MUI SCIENTIFIC

The following data is part of a premarket notification filed by Mui Scientific with the FDA for Rapid Barostat Bag (rbb) Pump And Catheter.

Pre-market Notification Details

Device IDK160287
510k NumberK160287
Device Name:Rapid Barostat Bag (RBB) Pump And Catheter
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant MUI SCIENTIFIC 145 TRADERS BLVD. EAST #33-34 Mississauga,  CA L4z 3l3
ContactTammy Mui
CorrespondentTammy Mui
MUI SCIENTIFIC 145 TRADERS BLVD. EAST #33-34 Mississauga,  CA L4z 3l3
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-03
Decision Date2017-03-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00678467505118 K160287 000

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