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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 K904185
Device Name SENSATRACE
Applicant
Ludlow Corp., Technical Papers Division
Two Ludlow Park
Chicopee,  MA  01021
Applicant Contact JAY RUEHLEN
Correspondent
Ludlow Corp., Technical Papers Division
Two Ludlow Park
Chicopee,  MA  01021
Correspondent Contact JAY RUEHLEN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/12/1990
Decision Date 10/31/1990
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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