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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 K043370
Device Name PLANET 50 MONITORING SYSTEM
Applicant
Larsen & Toubro Limited
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/08/2004
Decision Date 02/15/2005
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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