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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 K092153
Device Name SKYLINE 55, MODEL VER 1
Applicant
Larsen & Toubro Limited
1051 Perimeter Dr., Suite 470
Schaumburg,  IL  60173
Applicant Contact SHAILESH BHOSALE
Correspondent
Larsen & Toubro Limited
1051 Perimeter Dr., Suite 470
Schaumburg,  IL  60173
Correspondent Contact SHAILESH BHOSALE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/16/2009
Decision Date 11/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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