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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 K081148
Device Name SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact SHEILA PICKERING
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Correspondent Contact SHEILA PICKERING
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received04/22/2008
Decision Date 12/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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