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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 K902407
Device Name NF-50-E DISPOSABLE ECG ELECTRODE
Applicant
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Applicant Contact JOHN I ALBER
Correspondent
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Correspondent Contact JOHN I ALBER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/31/1990
Decision Date 07/31/1990
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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