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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K131860
Device Name VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
Applicant
Us Vascular, LLC
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Us Vascular, LLC
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number870.2880
Classification Product Code
JOP  
Date Received06/24/2013
Decision Date 09/27/2013
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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