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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 K970627
Device Name E. CAM COINCIDENCE MODE (CM)
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact PAUL G ORIS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact PAUL G ORIS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/19/1997
Decision Date 09/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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