NPB-295 PULSE OXIMETER

Oximeter

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Npb-295 Pulse Oximeter.

Pre-market Notification Details

Device IDK973147
510k NumberK973147
Device Name:NPB-295 PULSE OXIMETER
ClassificationOximeter
Applicant NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa,  KS  66219 -2301
ContactRoger D Brown
CorrespondentRoger D Brown
NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa,  KS  66219 -2301
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-22
Decision Date1997-11-14
Summary:summary

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