FDA.reportPublic FDA data

510(k) K223696

Device
F&P Solo Mask Range
Applicant
Fisher & Paykel Healthcare, Ltd.
510(k) number
K223696
Product code
BZD
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-17
Date received
2022-12-09
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

Applicant Contact#

Contact
Reena Daken
Address
15 Maurice Paykel Pl., E. Tamaki Auckland NZ 2013 2013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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