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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 K922171
Device Name CENTRA II ANALYSIS SYSTEM
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact KRISTIN PABST
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact KRISTIN PABST
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/08/1992
Decision Date 12/28/1992
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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