Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

Oximeter

Covidien Llc

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Nellcor Oxysoft Neonatal-adult Spo2 Sensor, Oxysoftn, Nellcor Oxysoft Neonatal-adult Spo2 Sensor, Oxysoftnhc.

Pre-market Notification Details

Device IDK212555
510k NumberK212555
Device Name:Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
ClassificationOximeter
Applicant Covidien Llc 6135 Gunbarrel Avenue Boulder,  CO  80301
ContactAnushka Jayaraman
CorrespondentGreeshma Kayala
Covidien Llc 6135 Gunbarrel Avenue Boulder,  CO  80301
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-13
Decision Date2022-05-06

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