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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K213974
Device Name GEM FLOW COUPLER Monitor (GEM1020M-2)
Applicant
Synovis Micro Companies Alliance, Inc.
(A Subsidiary Of Baxter International Inc.)
439 Industrial Ln.
Birmingham,  AL  35211
Applicant Contact Russell Pagano
Correspondent
Synovis Micro Companies Alliance, Inc.
(A Subsidiary Of Baxter International Inc.)
439 Industrial Ln.
Birmingham,  AL  35211
Correspondent Contact Julie S. Carlston
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Code
MVR  
Date Received12/20/2021
Decision Date 04/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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