FDA.report

510(k) K171212

Device
AirFit N20
Applicant
ResMed Ltd
510(k) number
K171212
Product code
BZD  
Decision
Substantially Equivalent (SESE)
Decision date
2017-09-28
Date received
2017-04-25
Regulation
868.5905
Classification name
Ventilator, Non-continuous (respirator)
Medical specialty
Anesthesiology
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
Kim Kuan LEE
Address
1 Elizabeth Macarthur Dr. Bella Vista Nsw 2153 AU 2153 2153

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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