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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(with arrhythmia detection or alarms)
510(k) Number K090443
Device Name PLANET 55, MODEL 100
Applicant
LARSEN & TOUBRO LIMITED
1468 HARWELL AVE.
CROFTON,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
LARSEN & TOUBRO LIMITED
1468 HARWELL AVE.
CROFTON,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/20/2009
Decision Date 06/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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