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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 K082366
Device Name LIFEBED PATIENT VIGILANCE SYSTEM
Applicant
Hoana Medical, Inc.
828 Fort St. Mall
Suite 620
Honolulu,  HI  96825
Applicant Contact NANCY GERTLAR
Correspondent
Hoana Medical, Inc.
828 Fort St. Mall
Suite 620
Honolulu,  HI  96825
Correspondent Contact NANCY GERTLAR
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/18/2008
Decision Date 09/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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