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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 K842616
Device Name SPACELABS ALPHA PC PATIENT COMPUTER
Applicant
SPACELABS, INC.
20550 PRAIRIE ST.
CHATSWORTH,  CA  91311
Applicant Contact WILLIAM M FRANK
Correspondent
SPACELABS, INC.
20550 PRAIRIE ST.
CHATSWORTH,  CA  91311
Correspondent Contact WILLIAM M FRANK
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/05/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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