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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 K972498
Device Name OBSERVER * CENTRAL STATION
Applicant
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Applicant Contact DARLENE T KORAB
Correspondent
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Correspondent Contact DARLENE T KORAB
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/03/1997
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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