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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multivariate Vital Signs Index
510(k) Number K230386
Device Name SpassageQ
Applicant
Spass, Inc.
Unit 905, 396 World Cup Buk-Ro, Mapo-Gu
Seoul,  KR 03925
Applicant Contact Yonghwan Kim
Correspondent
Radios, LLC
4408 Tortuga Ln
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number870.2300
Classification Product Code
PLB  
Date Received02/14/2023
Decision Date 06/15/2023
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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