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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 K101850
Device Name SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
Applicant
Spacelabs Healthcare, Ltd.
P.O. Box 3018
Nederland,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
Spacelabs Healthcare, Ltd.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/01/2010
Decision Date 03/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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