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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K852543
Device Name KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
Applicant
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Applicant Contact GEORGE CHO
Correspondent
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Correspondent Contact GEORGE CHO
Regulation Number870.2330
Classification Product Code
DXK  
Date Received06/14/1985
Decision Date 09/20/1985
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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