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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 K010482
Device Name ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
Applicant
Echocath, Inc.
4326 U.S. Rte. #1
Monmouth Junction,  NJ  08852
Applicant Contact DAVID LYONS
Correspondent
Echocath, Inc.
4326 U.S. Rte. #1
Monmouth Junction,  NJ  08852
Correspondent Contact DAVID LYONS
Regulation Number870.2880
Classification Product Code
JOP  
Subsequent Product Code
DPW  
Date Received02/20/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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