FDA.report

510(k) K251661

Device
Mariana Minerva; Mariana Nimbus
Applicant
Resmed Pty , Ltd.
510(k) number
K251661
Product code
MNS
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-23
Date received
2025-05-30
Regulation
868.5895
Classification name
Ventilator, Continuous, Non-Life-Supporting
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nerida Hunt
Address
1 Elizabeth Macarthur Dr. Bella Vista AU 2153 2153

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code MNS

510(k)DeviceApplicantDecision date
K251889myAirResmed Corp2026-04-08
K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.2026-03-17
K240778Vivo 1, Vivo 2Breas Medical AB2024-12-13
K231064ReddyPort ElbowSmd Manufacturing, LLC2023-07-13
K213169BPAP SystemBMC Medical Co., Ltd.2022-12-05
K171827ReddyPort NIV Access ElbowSmd Manufacturing, LLC2018-01-19
K161492Juno VPAP ST-AResmed, Ltd.2017-01-19
K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.2016-09-09
K153061Juno VPAP ST-AResmed, Ltd.2016-04-13
K132371EASYCARE ONLINEResmed, Ltd.2013-11-22
K123511S9 VPAP TXResmed, Ltd.2013-03-21
K123557EASYCARE ONLINEResmed, Ltd.2013-03-14
K122324VPAP S-AResmed, Ltd.2012-11-13
K113714VPAP TXResmed, Ltd.2012-05-25
K113288VPAP ST-AResmed, Ltd.2012-03-29