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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 K852968
Device Name PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
Applicant
Personal Computers For Medicine, Inc.
750 Welch Rd. Suite 225
Palo Alto,  CA  94304
Applicant Contact JOSEPH P ILVENTO
Correspondent
Personal Computers For Medicine, Inc.
750 Welch Rd. Suite 225
Palo Alto,  CA  94304
Correspondent Contact JOSEPH P ILVENTO
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/15/1985
Decision Date 11/14/1985
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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