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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 K860834
Device Name SPACELABS MEDICAL WORKSTATION
Applicant
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Applicant Contact ALLEN M HANS
Correspondent
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Correspondent Contact ALLEN M HANS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/05/1986
Decision Date 04/29/1986
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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