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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 K010966
Device Name MEDLEY SP02 MODULE, MODEL 8220
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 Received04/02/2001
Decision Date 06/08/2001
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
Recalls CDRH Recalls
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