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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 K922668
Device Name PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
Applicant
Colin Medical Instruments Corp.
5850 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact SUSAN D GOLSTEIN-FA
Correspondent
Colin Medical Instruments Corp.
5850 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact SUSAN D GOLSTEIN-FA
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/04/1992
Decision Date 01/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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