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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K880498
Device Name RM-301 PATIENT MONITOR
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 Number870.2300
Classification Product Code
DRT  
Date Received02/05/1988
Decision Date 05/13/1988
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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