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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 K991671
Device Name HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Applicant Contact TERRENCE J SWEENEY
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Correspondent Contact TERRENCE J SWEENEY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/17/1999
Decision Date 06/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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