FDA.report

510(k) K212555

Device
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
Applicant
Covidien Llc
510(k) number
K212555
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-06
Date received
2021-08-13
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Anushka Jayaraman
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20884521818986Nellcor OxySoftCovidien LP2022-08-21
20884521819006Nellcor OxySoftCovidien LP2022-08-15
20884521818993Nellcor OxySoftCovidien LP2022-08-15
20884521818979Nellcor OxySoftCovidien LP2022-08-15

Legacy Summary

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FDA Review

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