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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K871325
Device Name BOWEN REUSEABLE/DISPOSABLE ELECTRODE
Applicant
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Applicant Contact SUSAN L BRANDT
Correspondent
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Correspondent Contact SUSAN L BRANDT
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/03/1987
Decision Date 06/08/1987
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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