FDA.reportPublic FDA data

510(k) K223120

Device
Ventoux VC2; Ventoux VC3
Applicant
Flight Medical Innovations , Ltd.
510(k) number
K223120
Product code
CBK
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2022-10-03
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
No

Applicant Contact#

Contact
Ken Raichman
Address
7 Hatnufa St. Petach Tikva IL 4951025 4951025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBK#

510(k), Device, Applicant table
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
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
K240807VM-2000Ventis Medical, Inc.2024-08-13
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