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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 K896775
Device Name PCI MODEL 2041-B TELEMETRY MONITOR
Applicant
Accucore, Inc.
2041-A So. Grande Ave.
Santa Ana,  CA  92705
Applicant Contact WILLIAM C MCBRIDE
Correspondent
Accucore, Inc.
2041-A So. Grande Ave.
Santa Ana,  CA  92705
Correspondent Contact WILLIAM C MCBRIDE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/01/1989
Decision Date 05/17/1990
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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