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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 K091408
Device Name DISPOSABLE PRESSURE TRANSDUCER
Applicant
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Suite 8d, Zhongxin Zhongshan
#19, Ln. 999 Zhongshan #2
Shanghai,  CN 200030
Applicant Contact LEE FU
Correspondent
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Suite 8d, Zhongxin Zhongshan
#19, Ln. 999 Zhongshan #2
Shanghai,  CN 200030
Correspondent Contact LEE FU
Regulation Number870.2850
Classification Product Code
DRS  
Date Received05/12/2009
Decision Date 08/18/2009
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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