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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 K992152
Device Name GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
102 FIRST ST. SOUTH
KALONA,  IA  52247
Applicant Contact J. WILLIAM JONES
Correspondent
CIVCO MEDICAL INSTRUMENTS CO., INC.
102 FIRST ST. SOUTH
KALONA,  IA  52247
Correspondent Contact J. WILLIAM JONES
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/25/1999
Decision Date 08/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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