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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 K182839
Device Name Lifetech Cardio Model 8301 Temporary Pacemaker
Applicant
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Rm.201, Bldg. #2, Huahan Sci-Tech Industrial Park,
#16 Jinniu W. Rd.
Shenzhen,  CN 518000
Applicant Contact Stephy Pan
Correspondent
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Rm.201, Bldg. #2, Huahan Sci-Tech Industrial Park,
#16 Jinniu W. Rd.
Shenzhen,  CN 518000
Correspondent Contact Stephy Pan
Regulation Number870.3600
Classification Product Code
DTE  
Date Received10/09/2018
Decision Date 02/28/2019
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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