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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 K872074
Device Name 5 MHZ TRANSDUCER
Applicant
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Applicant Contact ROBERT D WAXHAM
Correspondent
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Correspondent Contact ROBERT D WAXHAM
Regulation Number870.2880
Classification Product Code
JOP  
Date Received05/29/1987
Decision Date 08/25/1987
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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