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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 K981530
Device Name SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
Applicant
SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Applicant Contact RUSS GARRISON
Correspondent
SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Correspondent Contact RUSS GARRISON
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/29/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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