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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 K911320
Device Name EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE
Applicant
Applied Biometrics, Inc.
6269 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact CLAIRE T HOVLAND
Correspondent
Applied Biometrics, Inc.
6269 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact CLAIRE T HOVLAND
Regulation Number870.2880
Classification Product Code
JOP  
Date Received03/26/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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