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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 K051352
Device Name OXIMAX NPB-40 HANDHELD PULSE OXIMETER
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact SARAH HARRINGTON
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact SARAH HARRINGTON
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/24/2005
Decision Date 08/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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