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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K992731
Device Name E.CAM COMPUTER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact ROBERT W CALLAHAN
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact ROBERT W CALLAHAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/13/1999
Decision Date 11/10/1999
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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