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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 K930095
Device Name SPACELABS MEDICAL PATIENT MONITOR
Applicant
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact RAYMOND W GIFFORD
Correspondent
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact RAYMOND W GIFFORD
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/08/1993
Decision Date 09/03/1993
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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