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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 K091680
Device Name DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Applicant
Edan Instruments, Inc.
1 Odell Plaza
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYO  
Date Received06/10/2009
Decision Date 06/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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