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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 K911472
Device Name BIO-SENSOR 01 EKG ELECTRODE
Applicant
Bio-Sensor, Inc.
224 Old Brattleboro Rd.
Hinsdale,  NJ  03451
Applicant Contact RICK JOSE
Correspondent
Bio-Sensor, Inc.
224 Old Brattleboro Rd.
Hinsdale,  NJ  03451
Correspondent Contact RICK JOSE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/03/1991
Decision Date 10/10/1991
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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