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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K901514
Device Name XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
Applicant
Ppg Industries, Inc.
9910 Widmer Dr.
Lenexa,  KS  66215
Applicant Contact GREGORY A WHITNEY
Correspondent
Ppg Industries, Inc.
9910 Widmer Dr.
Lenexa,  KS  66215
Correspondent Contact GREGORY A WHITNEY
Regulation Number870.1110
Classification Product Code
DSK  
Date Received03/30/1990
Decision Date 11/16/1990
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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