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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 K081552
Device Name SKYLINE 55
Applicant
Larsen & Toubro Limited
Kiadb Industrial Area
Hebbal, Hottagalli
Mysore, Karnataka,  IN 570 018
Applicant Contact A B DESHPANDE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/03/2008
Decision Date 07/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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