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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 K021090
Device Name OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Applicant Contact GINA TO
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Correspondent Contact GINA TO
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/04/2002
Decision Date 05/08/2002
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
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