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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K954397
Device Name BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
Applicant
Koven Technology, Inc.
300 Brookes Dr.
Suite 105
St. Louis,  MO  63042
Applicant Contact PAUL G KOVEN
Correspondent
Koven Technology, Inc.
300 Brookes Dr.
Suite 105
St. Louis,  MO  63042
Correspondent Contact PAUL G KOVEN
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Code
JOP  
Date Received09/20/1995
Decision Date 03/29/1996
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
Recalls CDRH Recalls
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