MODEL 9600, AVANT PULSE OXIMETER

Oximeter

NONIN MEDICAL, INC.

The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 9600, Avant Pulse Oximeter.

Pre-market Notification Details

Device IDK023044
510k NumberK023044
Device Name:MODEL 9600, AVANT PULSE OXIMETER
ClassificationOximeter
Applicant NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis,  MN  55447 -4755
ContactRichard P Bennett
CorrespondentRichard P Bennett
NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis,  MN  55447 -4755
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-12
Decision Date2003-07-23
Summary:summary

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