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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 K912627
Device Name MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
Applicant
Ppg Industries, Inc.
16505 W. 113th St.
P.O. Box 15955
Lenexa,  KS  66215
Applicant Contact GREGORY A WHITNEY
Correspondent
Ppg Industries, Inc.
16505 W. 113th St.
P.O. Box 15955
Lenexa,  KS  66215
Correspondent Contact GREGORY A WHITNEY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/14/1991
Decision Date 09/10/1991
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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