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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, cardiac (incl. cardiotachometer & rate alarm)
510(k) Number K052446
Device Name LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
Applicant
HOANA MEDICAL, INC.
1001 BISHOP STREET, STE 2828
AMERICAN SAVINGS BANK TOWER
HONOLULU,  HI  96813
Applicant Contact MATTHEW S GLEI
Correspondent
HOANA MEDICAL, INC.
1001 BISHOP STREET, STE 2828
AMERICAN SAVINGS BANK TOWER
HONOLULU,  HI  96813
Correspondent Contact MATTHEW S GLEI
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/07/2005
Decision Date 02/02/2006
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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