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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 K022677
Device Name MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/12/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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