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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K935043
Device Name SIEMENS CLINICAL WORK STATION
Applicant
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact THOMAS W CONNELLY
Correspondent
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact THOMAS W CONNELLY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/21/1993
Decision Date 04/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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