FDA.report

510(k) K140159

Device
S9 WANDA VPAP ST
Applicant
RESMED LTD.
510(k) number
K140159
Product code
BZD  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-17
Date received
2014-01-22
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
JIM CASSI
Address
9001 Spectrum Center Blvd. San Diego CA US 92123 92123

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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