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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 doppler, ultrasonic
510(k) Number K980557
Device Name SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 S.E. 51ST ST.
ISSAQUAH,  WA  98029 -7298
Applicant Contact STEVE HESLER
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 S.E. 51ST ST.
ISSAQUAH,  WA  98029 -7298
Correspondent Contact STEVE HESLER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/13/1998
Decision Date 04/24/1998
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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