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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K171397
Device Name Sienna Ultimate Wireless Amplifier
Applicant
EMS Handels Gesellschaft m.b.H.
Jochingergasse 1
Korneuburg,  AT A-2100
Applicant Contact Ruzena Ortnerova
Correspondent
Smith Associates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GWQ  
Date Received05/11/2017
Decision Date 10/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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