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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K880505
Device Name ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
Applicant
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact STEVE BRODY
Correspondent
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact STEVE BRODY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/05/1988
Decision Date 12/27/1988
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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