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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K242623
Device Name Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
Applicant
Shenzhen Medke Technology Co., Ltd.
401, 503, Bldg. A1, Anle Ind. Zone # 172, Hangcheng Rd.
Sanwei Community, Hangcheng St., Baoan District
Shenzhen,  CN 518126
Applicant Contact Wei Tao Li
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/03/2024
Decision Date 10/31/2024
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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