FDA.report

510(k) K252078

Device
BreathePal Bilevel (GFM50-MD2201)
Applicant
Compal Electronics, Inc.
510(k) number
K252078
Product code
MNS
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-17
Date received
2025-07-02
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

Related Records

Applicant Contact

Contact
Casper Chen
Address
# 581 And 581-1, Ruiguang Rd., Neihu Dist. Taipei City TW 11492 11492

FDA Registration Numbers

Source Documents

510(k) summary PDF

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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