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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, Diagnostic
510(k) Number K935994
Device Name PW DOPPLER VASCULAR PROBES
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 Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
JAF  
Date Received12/15/1993
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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