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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, Pre-Programmed, Single-Function
510(k) Number K820820
Device Name CARDIO REVUE CENTER
Applicant
Diasonics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diasonics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1435
Classification Product Code
DXG  
Date Received03/24/1982
Decision Date 04/29/1982
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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