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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 K864505
Device Name SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
Applicant
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Applicant Contact HANS, P.E.
Correspondent
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Correspondent Contact HANS, P.E.
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/14/1986
Decision Date 11/24/1986
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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