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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 K980688
Device Name INTEGRITI PATIENT MONITOR
Applicant
Alliance Instruments
3112 NE 112th Ave., Suite C
Vancouver,  WA  98682
Applicant Contact JIM ROOKS
Correspondent
Alliance Instruments
3112 NE 112th Ave., Suite C
Vancouver,  WA  98682
Correspondent Contact JIM ROOKS
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/23/1998
Decision Date 03/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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