FDA.report

510(k) K213169

Device
BPAP System
Applicant
BMC Medical Co., Ltd.
510(k) number
K213169
Product code
MNS
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-05
Date received
2021-09-28
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
No

Related Records

Applicant Contact

Contact
Fang Zheng
Address
Rm. 901, Bldg. 1, #28 Pingguoyuan Rd. Beijing CN 100041 100041

FDA Registration Numbers

Source Documents

510(k) summary PDF

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
K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.2026-02-23
K240778Vivo 1, Vivo 2Breas Medical AB2024-12-13
K231064ReddyPort ElbowSmd Manufacturing, LLC2023-07-13
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