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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 K093017
Device Name STELLAR 300
Applicant
Larsen & Toubro Limited
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Larsen & Toubro Limited
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/29/2009
Decision Date 04/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01097603
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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