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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 K994373
Device Name HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)
Applicant
ATL ULTRASOUND, INC.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Applicant Contact TERRANCE J SWEEENEY
Correspondent
ATL ULTRASOUND, INC.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Correspondent Contact TERRANCE J SWEEENEY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/27/1999
Decision Date 03/24/2000
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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