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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K060058
Device Name STELLAR 404T
Applicant
Larsen & Toubro Limited
1821 Walden Office Sq.
Suite 400
Schaumburg,  IL  60173
Applicant Contact HARRY GUGNANI
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/09/2006
Decision Date 01/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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