FDA.report

510(k) K240807

Device
VM-2000
Applicant
Ventis Medical, Inc.
510(k) number
K240807
Product code
CBK
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-13
Date received
2024-03-25
Regulation
868.5895
Classification name
Ventilator, Continuous, Facility Use
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
Glenn Laub
Address
515 Executive Dr. Princeton NJ US 08540 08540

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.2025-12-31

Other 510(k) Records For Product Code CBK

510(k)DeviceApplicantDecision date
K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa2026-05-07
K252663Inbentus VersatileIconic Solutions by Murcia, SL2026-04-14
K251888VPAP Pediatric Face MaskHsiner Co., Ltd.2026-03-12
K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.2025-12-19
K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.2025-09-10
K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-08-28
K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.2025-05-08
K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.2024-12-30
K233486731 Series VentilatorZOLL Medical Corporation2024-12-13
K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations , Ltd.2024-12-02
K241135RESPOND(R) VentilatorCorvent Medical, Inc.2024-11-13
K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskSleepnet Corporation2024-08-28
K232836Family of DIMAR DMAX NIV masksDimar S.P.A.2024-08-14
K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskSleepnet Corporation2024-06-27
K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC2024-03-01