OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

Oximeter

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Pulse Oximetry System With N-595 Pulse Oximeter And Oximax Sensors And Cables (aka Accessories).

Pre-market Notification Details

Device IDK012891
510k NumberK012891
Device Name:OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
ClassificationOximeter
Applicant NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
ContactRonald J Ehmsen
CorrespondentRonald J Ehmsen
NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-28
Decision Date2002-03-07
Summary:summary

NIH GUDID Devices

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