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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 K934638
Device Name REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
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 Number870.2880
Classification Product Code
JOP  
Date Received09/24/1993
Decision Date 05/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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