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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 K934000
Device Name SENTRY AQUEOUS GEL ECG ELECTRODES
Applicant
Sentry Medical Products, Inc.
331 S. Eisenhower Ln.
Lombard,  IL  60148
Applicant Contact JAMES G STOKES
Correspondent
Sentry Medical Products, Inc.
331 S. Eisenhower Ln.
Lombard,  IL  60148
Correspondent Contact JAMES G STOKES
Regulation Number870.2360
Classification Product Code
DRX  
Date Received08/17/1993
Decision Date 08/30/1994
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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