GEM FLOW COUPLER Monitor (GEM1020M-2)

Flowmeter, Blood, Cardiovascular

Synovis Micro Companies Alliance, Inc.

The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Gem Flow Coupler Monitor (gem1020m-2).

Pre-market Notification Details

Device IDK213974
510k NumberK213974
Device Name:GEM FLOW COUPLER Monitor (GEM1020M-2)
ClassificationFlowmeter, Blood, Cardiovascular
Applicant Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.) 439 Industrial Lane Birmingham,  AL  35211
ContactRussell Pagano
CorrespondentJulie S. Carlston
Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.) 439 Industrial Lane Birmingham,  AL  35211
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-04-20

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