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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 K063690
Device Name COLIN PRESS MATE, MODEL BP S510
Applicant
Omron Healthcare, Inc.
3460 Pt.e Creek Ct. #102
Bonita Springs,  FL  34134
Applicant Contact RANNDY KELLOGG
Correspondent
Omron Healthcare, Inc.
3460 Pt.e Creek Ct. #102
Bonita Springs,  FL  34134
Correspondent Contact RANNDY KELLOGG
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DSK   DXN  
Date Received12/12/2006
Decision Date 05/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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