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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K113051
Device Name SPACELABS ARKON ANESTHESIA WORKSTATION
Applicant
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
BSZ  
Date Received10/13/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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