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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K951449
Device Name MODEL KM-25
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 Number892.1560
Classification Product Code
IYO  
Date Received03/29/1995
Decision Date 05/20/1996
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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