NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )

Oximeter

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Nellcor Portable Spo2 Patient Monitoring System ( Npspms ).

Pre-market Notification Details

Device IDK141542
510k NumberK141542
Device Name:NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
ClassificationOximeter
Applicant Covidien LLC 6135 Gunbarrel Ave Boulder,  CO  80301
ContactMia M Ware
CorrespondentMia M Ware
Covidien LLC 6135 Gunbarrel Ave Boulder,  CO  80301
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-10
Decision Date2014-10-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521208780 K141542 000
10884521215962 K141542 000
10884521215955 K141542 000
10884521215948 K141542 000
10884521215931 K141542 000
10884521208797 K141542 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.