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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K003663
Device Name SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
Applicant
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073 -9713
Applicant Contact IRENE JAWORSKI
Correspondent
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073 -9713
Correspondent Contact IRENE JAWORSKI
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received11/28/2000
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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