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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 K912714
Device Name RT40 RADIO TRANSLUCENT
Applicant
Bio-Detek, Inc.
453 S. Main St.,
P.O. Box 898
Attleboro,  MA  02703
Applicant Contact ROBERT E SIMMONS
Correspondent
Bio-Detek, Inc.
453 S. Main St.,
P.O. Box 898
Attleboro,  MA  02703
Correspondent Contact ROBERT E SIMMONS
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/18/1991
Decision Date 07/25/1991
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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