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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 K844632
Device Name INFANT LIMB ELECTRODE
Applicant
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Correspondent
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/27/1984
Decision Date 01/14/1985
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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