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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 K963707
Device Name NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact DONNA PAGE
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact DONNA PAGE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/16/1996
Decision Date 12/13/1996
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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