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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K201581
Device Name CPR BAND
Applicant
Credo
#302, 86, Baeul-Ro
Wonju-Si,  KR 26465
Applicant Contact Ji Hyo Wang
Correspondent
KMC, Inc.
Rm. # 904, 27
Digital-Ro 27ga-Gil, Guro-Gu
Seoul,  KR 08375
Correspondent Contact DongHa Lee
Regulation Number870.5210
Classification Product Code
LIX  
Date Received06/11/2020
Decision Date 03/06/2021
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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