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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K232721
Device Name Lifetech Cardio Temporary Pacemaker
Applicant
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
1401, Bldg. D1, Nanshan I Park
#1001, Xueyuan Ave., Taoyuan St., Nanshan District
Shenzhen,  CN 518000
Applicant Contact Stephy Pan
Correspondent
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
1401, Bldg. D1, Nanshan I Park
#1001, Xueyuan Ave., Taoyuan St., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Stephy Pan
Regulation Number870.3600
Classification Product Code
DTE  
Date Received09/05/2023
Decision Date 01/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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