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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K152472
Device Name Disposable Pressure Transducer
Applicant
Zhejiang Haisheng Medical Device Co., Ltd.
305#Tanggong Rd., Paojiang Industrial Zone
Shaoxing,  CN 312071
Applicant Contact Junbin Hu
Correspondent
Medwheat (Shanghai) Medical Technology Co. , Ltd.
Yangpu Distrist Liaoyuan E. Rd. Shuangyang
First Suite #33 Rm. 303
Shanghai,  CN 200093
Correspondent Contact Jonathan Hu
Regulation Number870.2850
Classification Product Code
DRS  
Date Received08/31/2015
Decision Date 10/31/2016
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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