AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100

Oximeter

NONIN MEDICAL, INC.

The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Avant Digital Pulse Oximetry System, Model 4000, 4100.

Pre-market Notification Details

Device IDK052669
510k NumberK052669
Device Name:AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
ClassificationOximeter
Applicant NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth,  MN  55441 -5443
ContactLori M Roth
CorrespondentLori M Roth
NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth,  MN  55441 -5443
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-27
Decision Date2005-12-23
Summary:summary

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