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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 K071156
Device Name SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
Applicant
Sounmed, Inc.
6800 NW 77th. Ct.
Miami,  FL  33166
Applicant Contact JHOANA LORES
Correspondent
Sounmed, Inc.
6800 NW 77th. Ct.
Miami,  FL  33166
Correspondent Contact JHOANA LORES
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/25/2007
Decision Date 07/03/2007
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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