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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 K060576
Device Name NELLCOR OXIMAX N-600X PULSE OXIMETER
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact PATRICK GARVEY
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact PATRICK GARVEY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/06/2006
Decision Date 08/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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