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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 K875272
Device Name SONOLINE CF
Applicant
Siemens Medical Laboratories, Inc.
Ultrasound Division
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Applicant Contact K JOHNSON
Correspondent
Siemens Medical Laboratories, Inc.
Ultrasound Division
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Correspondent Contact K JOHNSON
Regulation Number870.2330
Classification Product Code
DXK  
Date Received12/24/1987
Decision Date 02/18/1988
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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