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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K874327
Device Name SKIN PREP ANALYZER
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact THOMAS MASSOPUST
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact THOMAS MASSOPUST
Regulation Number870.2370
Classification Product Code
KRC  
Date Received10/21/1987
Decision Date 11/23/1987
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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