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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K192092
Device Name Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
Applicant
Seca GmbH & Co. KG
Hammer Steindamm 3-25
Hamburg,  DE 22089
Applicant Contact Corinna Hatje
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Oliver Eikenberg
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   FLL  
Date Received08/05/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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