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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 K151040
Device Name Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
Applicant
BIOMETRIX LTD.
KIRYAT MADA 4
JERUSALEM,  IL 91450
Applicant Contact Zoya Lee
Correspondent
BIOMETRIX LTD.
KIRYAT MADA 4
JERUSALEM,  IL 91450
Correspondent Contact Zoya Lee
Regulation Number870.2850
Classification Product Code
DRS  
Date Received04/20/2015
Decision Date 09/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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