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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K864279
Device Name SPACELABS MODEL 90419 PULSE OXIMETER MODULE
Applicant
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Applicant Contact ALLEN HANS
Correspondent
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Correspondent Contact ALLEN HANS
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/30/1986
Decision Date 03/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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