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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 K840875
Device Name MULTIVARIATE DIGITAL CARDIOGRAPH
Applicant
Clinical Microsystems Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Clinical Microsystems Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/27/1984
Decision Date 07/06/1984
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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