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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 K945773
Device Name SIEMENS SONOLINE VERSA
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 S.E. 51ST ST.
ISSAQUAH,  WA  98027 -7002
Applicant Contact STEVE HESLER
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 S.E. 51ST ST.
ISSAQUAH,  WA  98027 -7002
Correspondent Contact STEVE HESLER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/25/1994
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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